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Search Results Within Category "Asthma/Lung Disease"

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

39 Study Matches

Use of Hyperpolarized 129Xe MR Lung Imaging in Adults for Calibration (HpXeMRCal)

The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas MRI for regional assessment of lung function in a normal population of adults for the purposes of obtaining optimal images through MRI.

- jason.woods@cchmc.org

ALL
18 years and over
PHASE1
This study is also accepting healthy volunteers
NCT02316379
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Inclusion Criteria:
* Adults ages 18 years and older * Participant must be able to hold their breath for up to 16 seconds
Exclusion Criteria:
* History of heart defect * Pregnancy or positive pregnancy test * History of uncontrolled asthma defined for this study as requiring use of rescue inhaler ≥ 2 times in past month. * Symptoms of respiratory infection (loose or productive cough or wheeze), chest tightness, or sinus infection within past week. * Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula. * Participant is claustrophobic and unable to tolerate the imaging. * Standard MRI exclusions (metal, implants).
DRUG: Hyperpolarized 129 Xenon, DEVICE: MRI
Respiratory Disorders
Respiratory
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Streamlined Treatment of Pulmonary Exacerbations in Pediatrics (STOP PEDS RCT)

The STOP PEDS RCT is a multicenter, parallel, open label randomized controlled trial evaluating the long-term (one year) and short-term safety and efficacy of two antibiotic treatment strategies for the management of outpatient pulmonary exacerbations (PEx) in the pediatric CF population.

Sharon Kadon - sharon.kadon@cchmc.org

ALL
3 years to 18 years old
NA
This study is NOT accepting healthy volunteers
NCT06654752
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Inclusion Criteria:

• Age
• For main cohort and non-HEMT cohort: age 6 to \<19 years
• For preschool cohort: age 3 to \<6 years
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
• sweat chloride ≥ 60 mEq/liter
• two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
• Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability of participant to comply with the requirements of the study
• Highly Effective Modulator Therapy
• For main cohort and preschool cohort: Taking HEMT for at least 3 months at enrollment
• For non-HEMT cohort: not eligible for HEMT based on CFTR genotype or eligible but not taking for at least 3 months and no plans to start HEMT in the next year, and also not taking tezacaftor-ivacaftor or lumacaftor-ivacaftor for at least 3 months
• For main cohort and non-HEMT cohort: able to perform acceptable and reproducible spirometry
• For main cohort and non-HEMT cohort: ppFEV1 ≥ 50% predicted at enrollment based on the Global lung Initiative (GLI) reference equations
• Ability to receive text messages and access the internet
Exclusion Criteria:

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the individual or the quality of the data
• Receiving an acute course of oral or IV antibiotics at the time of enrollment or within the 14 days prior to enrollment. Individuals may be re-screened ≥21 days after completion of antibiotics if they are at their baseline state of health, per self-report
• Treatment with systemic corticosteroids at enrollment or within the 14 days prior to enrollment. Individuals may be re- screened ≥21 days after completion of systemic corticosteroids if they are at their clinical baseline, per self-report
• History of solid organ transplant
• History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment
• Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment
• Three or more IV antibiotic-treated PEx in the 12 months prior to enrollment
• Treatment with chronic oral antibiotics other than azithromycin at enrollment
• Treatment with systemic corticosteroids for allergic bronchopulmonary aspergillosis (ABPA) in the 12 months prior to enrollment
OTHER: Immediate Oral Antibiotics, OTHER: Tailored Treatment: Oral Antibiotics only if Additional Treatment needed
Cystic Fibrosis
cystic fibrosis, oral antibiotics, pulmonary exacerbation, pediatric
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Protocol CAUSE-03 / CHEETAH (CHEETAH)

This is a one-year longitudinal, observational study of 250 urban children and adolescents with asthma and 60 without asthma, ages 6-17 years old. Participants with asthma will require daily controller therapy with inhaled corticosteroids ICS (at least Step 2 therapy). Those without asthma cannot have used asthma medications in the year prior to enrollment and cannot demonstrate bronchodilator reversibility at baseline. Phenotypic characteristics will be established at baseline, and the participants will be seen at scheduled visits over 12 months. Each participant will be asked to monitor and self-report cold symptoms and will be asked to complete up to three cold visits

Molly Brausch-Bradner - Molly.Brausch-bradner@cchmc.org

ALL
6 years to 17 years old
This study is also accepting healthy volunteers
NCT06136091
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Inclusion Criteria:

• Participant and/or parent guardian must be able to understand and provide informed consent and assent
• Have a primary place of residence in one of the pre-selected recruitment census tracts as outlined in the Protocol CAUSE-03 Manual of Operations (MOP) a. Participants who do not live in the pre-selected census tracts but live within the Office of Management and Budget (OMB) defined Metropolitan Statistical Area and have publicly funded health insurance will qualify for inclusion
• Either:
• Have had a diagnosis of asthma made \> 1 year prior to recruitment; participants who received an asthma diagnosis by a clinician \<= 1 year prior to recruitment must report that their respiratory symptoms were present for more than 1 year prior to recruitment (asthma group), or
• No report of ever being diagnosed with asthma (non-asthma group)
• Either:
• Require at least Step 2 therapy at the Screening/Enrollment Visit (asthma group), or
• Have not used any asthma medications in the prior year (non-asthma group)
• Are able to perform acceptable and repeatable spirometry per American Thoracic Society (ATS) criteria prior to enrollment
• Have documentation of current medical insurance with prescription coverage at the Screening/Enrollment Visit
• Participant and/or parent guardian has a smartphone compatible with the study electronic Patient Reported Outcomes (ePRO) system, Medidata Patient Cloud, and is willing to download one application for study use
Exclusion Criteria:

• Parent or guardian is not able or willing to give written informed consent or comply with study protocol
• Have concurrent medical problems that would require systemic corticosteroids or other immunomodulators during the study
• Are currently receiving immunotherapy
• Are currently receiving treatment with a biologic therapy or have received a biologic therapy within 3 months prior to enrollment
• Are currently requiring greater than fluticasone 500 mcg bid plus Long-Acting Beta Agonists (LABA) one puff twice daily or its equivalent plus Long Acting Muscarinic Antagonists (LAMA) and/or individuals using oral corticosteroids daily or every other day for more than 14 days at the time of the Screening/Enrollment Visit
• Are currently pregnant or lactating, or plan to become pregnant during the time of study participation. Females of child-bearing potential (post-menarche) must be abstinent or use a medically acceptable birth control method throughout the study (i.e., oral subcutaneous, mechanical, or surgical contraception)
• Have a known, pre-existing clinically important lung condition other than asthma.
• Have a current malignancy or previous history of cancer in remission for less than 12 months prior to enrollment
• Have a known immunodeficiency disease
• Use of investigational drugs within 4 weeks of enrollment
• Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the site investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study
• If in the asthma group, will not allow the study clinician, an asthma specialist, to manage their disease for the duration of the study or who are not willing to change their asthma medications to follow Protocol CAUSE-03 CHEETAH
• If in the non-asthma group, having bronchodilator reversibility (improvement in Forced expiratory volume in 1 second (FEV1) with albuterol \> = 10%) at the Screening/Enrollment visit
• Have had a life-threatening asthma exacerbation in the last 2 years requiring intubation, mechanical ventilation or resulting in a hypoxic seizure. Potential participants may be reassessed as outlined in the Protocol CAUSE-03 Manual of Procedures (MOP)
Asthma
Asthma, Observational study, Children
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TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age (TIDES 2)

This is a longitudinal, observational epidemiological study designed to estimate the prevalence of depression, anxiety, and behavior problems in children ages 18 months through 11 years with cystic fibrosis (CF).

Stephanie Filigno, PhD - stephanie.filigno@cchmc.org

ALL
18 months to 11 years old
This study is NOT accepting healthy volunteers
NCT07048574
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Inclusion Criteria:

• Child with a diagnosis of Cystic fibrosis (CF) actively followed by the CF care team at a participating site
• Child is age 18 months thru 11 years
• English and/or Spanish speaking
• Parent/legal guardian willing and able to give informed consent, and for minor participants ages 7 thru 11 years able to give assent.
Exclusion Criteria:
* Unable or unwilling to participate in study procedures, or at Site PI discretion.
Cystic Fibrosis (CF)
Cystic Fibrosis, Children, Mental health screening, Depression, Anxiety, CFTR modulators, Neuropsychiatric adverse events
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Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia (FETO)

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses.

Sandi Bechtol - sandra.bechtol@cchmc.org

FEMALE
18 years to 50 years old
NA
This study is also accepting healthy volunteers
NCT02986087
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Inclusion Criteria:
* Isolated CDH with liver up * Severe pulmonary hypoplasia with ultrasound O/E LHR \<25% at the time of surgery * Gestational age at FETO procedure 27 weeks 0 days to 29 weeks 6 days * Moderate pulmonary hypoplasia with ultrasound O/E LHR \<30% and liver-up at the time of surgery * Gestational age at FETO procedure 30 weeks 0 days to 31 weeks 6 days in this moderate category * Maternal age greater than or equal to 18 years * Gestational age at enrollment prior to 29 weeks 6 days, or 31 weeks 6 days in moderate category * Normal karyotype or FISH * Normal fetal echocardiogram * Singleton pregnancy * Willing to remain in the greater Cincinnati area for remainder of pregnancy * Family considered and decline option of termination of the pregnancy at less than 24 weeks 0 days * Family meets psychosocial criteria
Exclusion Criteria:
* Patient \< 18 years old * Multi-fetal pregnancy * Rubber latex allergy * Preterm labor, cervix shortened (\<15 mm) or uterine anomaly strongly predisposing to preterm labor, placenta previa * Bilateral CDH, isolated left sided CDH with an O/E \> 30% * Additional fetal anomaly by ultrasound, MRI, or echocardiogram * Chromosomal abnormalities * Maternal contraindications to fetoscopic surgery or severe maternal condition in pregnancy * Incompetent cervix with or without a cerclage * Placental abnormalities known at time of enrollment * Maternal HIV, Hepatits B, Hepatitis C * Maternal uterine anomaly * No safe or technically feasible fetoscopic approach to balloon placement * Participation in another intervention study that influences maternal and fetal morbidity and mortality or participation in this trial in a previous pregnancy
DEVICE: Fetal Tracheal Occlusion
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary, Hypertension
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Registry of Asthma Characterization and Recruitment 3 (RACR3) (RACR3)

This is a multi-center, non-interventional registry to create and maintain a database of participants to serve as a recruitment source for current and future DAIT NIAID-sponsored Childhood Asthma in Urban Settings (CAUSE) studies.

Kathryn Geil - kathryn.geil@cchmc.org

ALL
This study is also accepting healthy volunteers
NCT05272241
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Inclusion Criteria:

• Participant is either:
• At least 18 years old, willing and able to provide informed consent at the time of enrollment
• Under the age of 18, accompanied by a legal guardian who is willing and able to provide informed consent at the time of enrollment
• Participant has a primary place of residence within the Office of Management and Budget (OMB)-defined Metropolitan Statistical Area (MSA)
Exclusion Criteria:

• Participant does not speak English or Spanish and/or guardian does not speak English or Spanish
• Participant does not have access to a phone, either personal or public, with regularity that could be used for scheduling and safety follow-up
• Past or current medical problems or findings from physical examination or laboratory testing, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may affect the quality or interpretation of the data obtained from the study Participants who are pregnant or lactating will not be excluded or discontinued from the study, but will not undergo any procedures that are prohibited during pregnancy per the Childhood Asthma in Urban Settings 02 (CAUSE-02) Registry for Asthma Characterization and Recruitment 3 (RACR3) Manual of Procedures (MOP)(e.g., allergen skin testing, spirometry) during the pregnancy. Potential participants may be reassessed as outlined in the Protocol CAUSE-02 MOP.
Asthma
Asthma, Allergy, CAUSE, RACR
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Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young Children (BEGIN)

This is a two-part, multi-center, prospective longitudinal, exploratory study of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators and their impact on children with cystic fibrosis (CF).

Kelly Thornton - kelly.thornton@cchmc.org

ALL
Up to 10 years old
This study is NOT accepting healthy volunteers
NCT04509050
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Inclusion Criteria:
* Part A: * Less than 10 years of age at the first study visit. * Documentation of a CF diagnosis. Part B: * Participated in Part A OR less than 7 years of age at the first study visit. * Documentation of a CF diagnosis. * CFTR mutations consistent with FDA labeled indication of highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor). * Physician intent to prescribe ivacaftor or elexacaftor/tezacaftor/ivacaftor.
Exclusion Criteria:
* Part A and Part B: * Use of an investigational drug within 28 days prior to and including the first study visit. * Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor within the 28 days prior to and including the first study visit. * Use of chronic oral corticosteroids within the 28 days prior to and including the first study visit.
DRUG: Ivacaftor or elexacaftor/tezacaftor/ivacaftor
Cystic Fibrosis
Cystic Fibrosis, CF, CFTR Modulator, triple combination therapy, elexacaftor, tezacaftor, ivacaftor
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Regional Monitoring of CF Lung Disease

The main reason for this research study is to learn more about some new tests that are being developing for patients with Cystic Fibrosis (CF) to measure changes in the lungs. In this study, the focus will be to learn how stopping Airway Clearance (ACT) and re-starting ACT can affect these tests. These new tests include using a breathable gas called Xenon (Xe) with MRI (magnetic resonance imaging) to improve the pictures of changes in the lungs. The Xenon (Xe) gas that has been treated to have a larger MRI signal (also called hyperpolarized). The other new test is called LCI (Lung Clearance Index) that can measure how well the lungs are working. The MRI machine used in this study has been approved by the U.S. Food and Drug Administration (FDA) and is commercially available for sale in the USA. Hyperpolarized Xe gas is an FDA-approved, inhaled contrast agent for lung ventilation MRI. The new Xe MRI techniques that are being developed and used for this research study are investigational, meaning these new Xe MRI techniques are not FDA approved, but they are similar to FDA-approved techniques that are used clinically at Cincinnati Children's Hospital Medical Center (CCHMC). Xe gas and the new MRI techniques used in this research study have been used for many years in research, including in many research studies conducted at CCHMC like this one.

Carrie Stevens, BS - carrie.stevens@cchmc.org

ALL
12 years to 21 years old
EARLY_PHASE1
This study is NOT accepting healthy volunteers
NCT06339593
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Inclusion Criteria:
* 1 Written informed consent (and assent when applicable) obtained from subject or subject's legal representative. 2 Use of highly effective modulators for more than 30 days (ie. Trikafta) 3 Willingness and ability to adhere to the study visit schedule and other protocol requirements. 4 Documentation of a CF diagnosis with prescription of Mechanical ACT 5 Ages 12-21 inclusive, at the time of consent. 6 Clinically stable with no respiratory tract infection or recent exacerbations. 7 Treating CF physician agreeable to study procedures. Only applicable to Aim 3. 8 No change in chronic maintenance therapies in the 28 days prior to enrollment. 9 Ability to cooperate with MRI procedures.
Exclusion Criteria:

• Standard MRI exclusions (metal implants, claustrophobia).
• For females of childbearing potential: Positive urine pregnancy test or Lactating.
• Acute respiratory symptoms (e.g., wheezing) at the time of the MRI
• Chronic lung or liver or pancreatic disease not related to CF.
• Any other condition that, in the opinion of the Investigator, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives.
PROCEDURE: Airway-clearance vest, DRUG: Hyperpolarized Xe129
Cystic Fibrosis
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Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study

This study will seek to enroll immunocompromised patients with Lower Tract parainfluenza infection. It also contains a sub-study to enroll patients with severe COVID-19.

Caitlin Caitlin Brammer - Caitlin.Brammer@cchmc.org

ALL
PHASE3
This study is NOT accepting healthy volunteers
NCT03808922
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Inclusion Criteria:

• At the time of randomization, requires supplemental oxygen ≥2 LPM due to hypoxemia.
• Immunocompromised, as defined by one or more of the following: * Received an autologous or allogeneic hematopoietic stem cell transplantation (HSCT) at any time in the past * Received a solid organ transplant at any time in the past * Has been or is currently being treated with chemotherapy for hematologic malignancies (e.g., leukemia, myeloma, lymphoma) and/or solid tumor malignancies (e.g., lung, breast, brain cancer) at any time in the past * Has an immunodeficiency due to congenital abnormality (only applicable to subjects age \< 18 years old) or pre-term birth (only applicable to subjects age ≤ 2 years old)
• Has, within 3 days prior to randomization, a confirmed LRTI with a sialic acid dependent respiratory virus
• If female, subject must meet one of the following conditions: * Not be of childbearing potential or * Be of childbearing potential and have a negative urine/serum pregnancy test and agrees to practice an acceptable method of contraception
• Non-vasectomized males are required to practice effective birth control methods
• Capable of understanding and complying with procedures as outlined in the protocol
• Provides signed informed consent prior to the initiation of any screening or study-specific procedures For COVID-19 sub study:
• Be ≥18 years of age
• Provide adequate medical history to permit accurate stratification (but health status may be healthy, high-risk conditions, or immunocompromised).
• Prior to SARS CoV 2 infection, has the ability to carry out self-care activities of daily living (basic ADL)
• Have lower respiratory tract infection (LRTI) confirmed by CT imaging, with or without contrast, to involve at least 2 lobes of the lung.
• Has laboratory-confirmation of the presence of SARS CoV 2 in the respiratory tract by at least one of the following samples
• Satisfy inclusion criteria #1, 4, 5, 6, 7 of the main study
Exclusion Criteria:

• Subjects may not be on hospice care or, in the opinion of the investigator, have a low chance of survival during the first 10 days of treatment
• Subjects with Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), or Alkaline Phosphatase (ALP) ≥3x ULN and Total Bilirubin (TBILI) ≥2x ULN Note: Subjects with ALT/AST/ALP ≥ 3x ULN AND TB ≥2x ULN that have been chronically stable (for \>1 year on more than one assessments) due to known liver pathology including malignancy (primary or metastasis), chronic medications, transplantation, or chronic infection will not be excluded
• Female subjects breastfeeding or planning to breastfeed at any time through 30 days after the last dose of study drug
• Subjects taking any other investigational drug used to treat pulmonary infection.
• Psychiatric or cognitive illness or recreational drug/alcohol use that, in the opinion of the principal investigator, would affect subject safety and/or compliance
• Subjects with known hypersensitivity to DAS181 and/or any of its components
• Subjects with severe sepsis due to either their baseline SAD-RV infection or a concurrent viral, bacterial, or fungal infection and meet at least one of the following criteria: * Has evidence of vital organ failure outside of the lung (e.g., liver, kidney) * Requires vasopressors to maintain blood pressure For COVID-19 sub study:
• Subjects requiring invasive mechanical, Bi-PAP or CPAP ventilation at randomization.
• Subjects receiving any other investigational or empiric treatment for SARS-2-CoV (either as part of a clinical trial or under emergency approval (approved agents for the management of symptoms, e.g., fever, are permitted).
• Subjects who are known HIV-positive (and not undetectable at most recent HIV RNA assessment)
• Subjects who are currently taking immunomodulating biologics (e.g, interferons, interleukin)
• Subjects with severe sepsis due to either their SARS-CoV-2 infection or a concurrent viral, bacterial, or fungal infection and meeting at least one of the following criteria: * Have evidence of vital organ failure outside of the lung (e.g., liver, kidney) * Require vasopressors to maintain blood pressure
• Subjects meeting exclusion criteria #2, 3, 5 and 6 of the main study
DRUG: DAS181, DRUG: Placebo, DRUG: DAS181 COVID-19, DRUG: DAS181 OL
Lower Respiratory Tract Infection, Parainfluenza, Immunocompromised, COVID-19
Parainfluenza, PIV, Immunocompromised, Lower Respiratory Tract Infection, LRTI, COVID19, SARS-CoV-2, Coronavirus, Ansun
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Abatacept for the Treatment of Common Variable Immunodeficiency With Interstitial Lung Disease (ABCVILD)

There is no standard of care therapy for patients with granulomatous-lymphocytic interstitial lung disease (GLILD) seen in common variable immunodeficiency (CVID). Abatacept has recently looked promising for the treatment of patients with complex CVID. This study is a multi-site, phase II, randomized, blinded/placebo-controlled clinical trial in pediatric and adult subjects to determine the efficacy of abatacept compared to placebo for treatment of subjects with GLILD in the context of CVID. Funding Source - FDA OOPD

Michael Jordan - Michael.Jordan@cchmc.org

ALL
4 years and over
PHASE2
This study is NOT accepting healthy volunteers
NCT04925375
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Inclusion Criteria:

• Diagnosis of CVID according to the international consensus document (ICON)
• Age 4 years or above
• Serum IgG at least 2 standard deviations below the age adjusted normal
• Decreased serum IgA and/or serum IgM
• Abnormal specific antibody response to immunization
• Exclusion of secondary immunodeficiency
• On replacement immunoglobulin for at least 6 months and willing to maintain throughout study
• Granulomatous-lymphocytic interstitial lung disease with a lymphocytic component diagnosed by lung biopsy prior to study entry, wedge biopsy preferred.
• Persistence or worsening of interstitial lung disease measured on serial CT imaging of the lung at least 6 months apart, with the latest assessment within 3 months of study entry.
• Signed written informed consent
• Willing to allow storage of biological specimens for future use in medical research.
• Female subjects of childbearing potential must agree to an effective form of birth control such as hormone based contraceptive, intrauterine device, condoms/barrier, surgically sterile partner, or abstinence.
• Fertile, non-vasectomized males with a female partner of childbearing potential should use condoms throughout the study and for 3 months after the last dose
Exclusion Criteria:

• History of hypersensitivity to abatacept or any of its components
• Has received any lymphocyte depleting agents including anti-CD20 monoclonal antibodies, alemtuzumab, ATG in the preceding 6 months
• Has received abatacept, cyclophosphamide, tumor necrosis factor inhibitors, or pulse steroids (defined as \>15mg/kg/day of methylprednisone or corticosteroid equivalent) within the past 3 months
• Have started or increased any of the following immune modulating drugs within 3 months of enrolling and 3 months from initial CT chest: azathioprine, cyclosporine, tacrolimus, mercaptopurine, methotrexate, mycophenolate mofetil, or sirolimus
• History of HIV infection (positive PCR)
• Chronic untreated hepatitis B or C (positive PCR)
• Active tuberculosis (TB) by positive QuantiFERON gold. If history of latent TB, then must supply evidence of completing treatment.
• Persistent Epstein-Barr Virus (EBV) load ≥ 1,000 units/mL blood checked twice at least 1 month apart
• Other uncontrolled infections
• Live vaccine given within 6 weeks of the start of the trial
• Malignancy or treated for malignancy within the past year
• Currently pregnant or breast feeding
• Life expectancy less than 1 month
• Subjects unwilling to self-administer or have a parent/caregiver self-administer subcutaneous injections at home
• Other conditions that the investigators feel contraindicate participation in the study Inclusion criteria for Extended Treatment Plan: * Patients must have completed the abatacept for the treatment of Interstitial Lung Disease in Common Variable Immunodeficiency (ABCVILD) trial * Patients must have demonstrated positive response to abatacept. * Patients must provide informed consent to participate in the Extended Treatment Plan. Exclusion criteria for Extended Treatment Plan: • Patients who experienced SAEs during the original trial, and such SAEs were determined as related to treatment, or patients who in the opinion of the investigator would not benefit from the extended treatment option.
DRUG: Abatacept, OTHER: Placebo
Interstitial Lung Disease, Common Variable Immunodeficiency
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Safety and Efficacy of FETO in CDH Phase III (CDH FETO)

Tracheal occlusion IDE approved by FDA for congenital diaphragmatic hernia fetuses and standard of care control group

Foong-Yen Lim - foong.yen.lim@cchmc.org

FEMALE
18 years to 50 years old
PHASE3
This study is also accepting healthy volunteers
NCT07187206
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Inclusion Criteria:
* Pregnant women 18 years and older, who are able to consent * Singleton pregnancy * Gestational age at enrollment is prior to 296 weeks * Intrathoracic liver herniation * Isolated Left CDH with o/e LHR \< 30% at enrollment (180 to 295 weeks) or * Isolated Right CDH with o/e LHR \< 45% at enrollment (180 to 295 weeks) * Normal fetal karyotype with confirmation by culture results, CMA with non-pathological variants, WES or WGS. Results by fluorescence in situ hybridization (FISH) will be acceptable if the patient is \> 26 weeks * Cervical length by transvaginal ultrasound \> 20 mm within 24 hours prior to FETO procedure * Patient meets psychosocial criteria * Informed consent understood Exclusion Criteria * Patient \< 18 years of age * Multi-fetal pregnancy * History of natural rubber latex allergy * Preterm labor, cervix shortened (\< 20 mm at enrollment or within 24 hours prior to FETO balloon insertion) or uterine anomaly strongly predisposing to preterm labor, or placenta previa. * Psychosocial ineligibility, precluding consent: * Inability to reside within 30 minutes of Cincinnati Children's Hospital Medical Center and inability to comply with the travel for the follow-up requirements of the trial. * The patient does not have a support person (e.g. spouse, partner, mother) available to stay with the patient for the duration of the pregnancy at Cincinnati Children's Hospital Medical Center. * Bilateral CDH, isolated LCDH with o/e LHR ≥ 30%, isolated RCDH with o/e LHR \> 45%, as determined by ultrasound. * No liver herniation into thoracic cavity * Additional fetal anomaly and chromosomal abnormalities, associated anomalies recognized to alter survival prognosis (i.e., congenital heart disease) or presence of an underlying genetic syndrome (i.e., Fryns) by ultrasound, MRI, or echocardiogram at the fetal treatment center. * Maternal contraindication to fetoscopic surgery or severe maternal medical condition in pregnancy * History of incompetent cervix with or without cerclage * Placental abnormalities (previa, abruption, accreta) known at time of enrollment * Maternal-fetal Rh isoimmunization, Kell sensitization or neonatal alloimmune thrombocytopenia affecting the current pregnancy * Maternal HIV, Hepatitis-B, Hepatitis-C positive because of the increased risk of transmission to the fetus during maternal-fetal surgery. If the patient's HIV status is unknown, the patient must be tested and found to have negative results before enrollment. * Positive Hepatitis B surface antigen or presence of Hepatitis C in maternal blood uterine anomaly such as Mullerian duct abnormality, large or multiple fibroids that prohibit safe fetoscopic procedure * There is no safe or technically feasible fetoscopic approach to balloon placement * Participation in another intervention study that influences maternal and fetal morbidity and mortality, or participation in this trial in a previous pregnancy
DEVICE: FETO, Fetal Endoluminal Tracheal Occlusion
Congenital Diaphragmatic Hernia, Pulmonary Hypoplasia, Pulmonary Hypertension
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Non-Invasive Diagnosis of Pediatric Pulmonary Invasive Mold Infections (DOMINIC)

This study will establish a non-invasive diagnostic approach and evaluate clinical outcomes for children at high-risk for pulmonary invasive fungal infection (PIFI).

Caitlin Brammer - caitlin.brammer@cchmc.org

ALL
120 days to 21 years old
This study is NOT accepting healthy volunteers
NCT03827694
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Inclusion Criteria:
* Males or females age \> 120 days and \< 22 years at any participating site * Have at least one of the following conditions associated with a known high incidence of IFI: hematopoietic stem cell transplantation (HSCT), aplastic anemia, bone marrow failure, primary or acquired immune deficiency, or malignancy * New (last 96 hours) radiographic evidence of at least one of the following: at least one nodular lesion greater than or equal to 5 mm in size, a wedge-shaped and segmental or lobar consolidation, a cavitary lesion, a lesion with a halo sign, a lesion with a reverse halo sign, or a lesion with an air crescent sign * Prolonged neutropenia (absolute neutrophil count \< 500 cells/µl for a period of ≥ 5 consecutive days) in 30 days prior to and including the day of qualifying chest MRI or CT scan date OR currently receiving systemic therapy for acute or chronic graft-versus-host disease (GVHD) OR presence of neutrophil dysfunction because of underlying acquired or primary immune deficiency (e.g. chronic granulomatous disease) on the date of the qualifying chest MRI or CT scan * Subject consent or parental/guardian permission (informed consent) and if appropriate, child assent
Exclusion Criteria:
* Weight \<3 kg, so as to not exceed 3 ml/kg in a single blood draw * Previous inclusion in this study
DIAGNOSTIC_TEST: Non-Invasive Testing for PIFI
Pulmonary Invasive Fungal Infections, Pulmonary Invasive Aspergillosis
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Simulation Trial of Telemedical Support for Paramedics (R01)

In the United States, the current standard of prehospital (i.e. outside of hospitals) emergency care for children with life-threatening illnesses in the community includes remote physician support for paramedics providing life-saving therapy while transporting the child to the hospital. Most prehospital emergency medical services (EMS) agencies use radio-based (audio only) communication between paramedics and physicians to augment this care. However, this communication strategy is inherently limited as the remote physician cannot visualize the patient for accurate assessment and to direct treatment. The purpose of this pilot randomized controlled trial (RCT) is to evaluate whether use of a 2-way audiovisual connection with a pediatric emergency medicine expert (intervention = "telemedical support") will improve the quality of care provided by paramedics to infant simulator mannequins with life threatening illness (respiratory failure). Paramedics receiving real-time telemedical support by a pediatric expert may provide better care due to decreased cognitive burden, critical action checking, protocol verification, and error correction. Because real pediatric life-threatening illnesses are rare, high stakes events and involve a vulnerable population (children), this RCT will test the effect of the intervention on paramedic performance in simulated cases of pediatric medical emergencies. The two specific aims for this research are: * Aim 1: To test the intervention efficacy by determining if there is a measurable difference in the frequency of serious safety events between study groups * Aim 2: To compare two safety event detection methods, medical record review, and video review

Bradford McClain - bradford.mcClain@cchmc.org

ALL
21 years and over
NA
This study is NOT accepting healthy volunteers
NCT06441760
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Inclusion Criteria:
* Certified Emergency Medical Technicians (EMTs), Advanced EMTs (AEMTs), and Paramedics (EMT-Ps) who provide direct scene response. * Board-certified Pediatric Emergency Medicine (PEM) and Emergency Medicine (EM) physicians whose practice includes online medical support for EMS are eligible. * The control arm will include physicians who provide radio/telephone support in usual care at each site. In the intervention arm, experts will be PEM with/without EMS board-certification as they have relevant pediatric training and experience.
Exclusion Criteria:
* EMS personnel providing interfacility transport and/or pediatric specialty transport * Resident physicians-in-training * Non-physician providers
OTHER: Video teleconsultation, OTHER: Audio support
Emergencies, Cardiopulmonary Arrest, Acute Respiratory Failure, Status Epilepticus
Prehospital emergency care, Emergency medical services (EMS), Paramedics, Infant simulator mannequins, Telemedical support, Critically ill infants and children, Pediatric emergencies
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Sinus Disease in Young Children With Cystic Fibrosis

This is a prospective, observational study examining the impact of highly effective cystic fibrosis transmembrane conductance regulator (CFTR) modulators on chronic rhinosinusitis (CRS) and olfactory dysfunction (OD) in young children with cystic fibrosis (YCwCF). This study involves two groups: children 2-8 years old, inclusive at initial visit, receiving highly effective modulator therapy (HEMT), and a control group of children 2-8 years old, inclusive at initial visit, not receiving HEMT. Outcomes will include sinus magnetic resonance imaging (MRI) scans, olfactory tests, and quality of life surveys obtained over a two-year period.

Megan Schmitt - megan.schmitt@cchmc.org

ALL
2 years to 8 years old
This study is NOT accepting healthy volunteers
NCT06191640
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Inclusion Criteria:
HEMT Group: * Children with documentation of a CF diagnosis * Age 2-8 years old at first study visit * CFTR mutation consistent with FDA labeled indication of highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor) * Clinician intent to prescribe ivacaftor or ETI so that enrollment is before start of HEMT Non-HEMT/Control Group: * Children with documentation of a CF diagnosis * Age 2-8 years at first study visit * Ineligible for highly effective modulator therapy (ivacaftor or elexacaftor/tezacaftor/ivacaftor) based on CFTR mutation or clinical decision not to initiate HEMT if eligible
Exclusion Criteria:
For Both Groups: * Use of an investigational drug within 28 days prior to the first study visit * Use of ivacaftor or elexacaftor/tezacaftor/ivacaftor within the 180 days prior to and including the first study visit * Use of chronic oral corticosteroids within the 28 days prior to and including the first study visit. * Sinus surgery within 180 days prior to the first study visit
DRUG: Ivacaftor or elexacaftor/tezacaftor/ivacaftor
Cystic Fibrosis in Children, Cystic Fibrosis, Chronic Rhinosinusitis (Diagnosis), Olfactory Disorder, Olfactory Impairment
Cystic Fibrosis, Chronic Rhinosinusitis, Olfactory Dysfunction
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A National Registry For Pulmonary Alveolar Proteinosis

The major goal of Part A of this study is to establish a National PAP Registry to help make reliable new research tests available to doctors to improve the diagnosis of PAP, increase awareness and knowledge of PAP, and give patients a 'seat at the table' in planning and conducting PAP research including the clinical testing of several new potential therapies. The major goal of Part B of this study is to define the natural history of autoimmune PAP (aPAP), develop a disease severity score that reflects how aPAP patients feel and function, and to develop and test novel tools to measure the severity of aPAP lung disease. Funding Source - FDA OOPD

Brenna Carey - Brenna.Carey@cchmc.org

ALL
This study is NOT accepting healthy volunteers
NCT02461615
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Inclusion Criteria for Part A and Part B: * Written informed consent and assent, if applicable Inclusion Criteria for Part A (Cross Sectional Study of PAP Syndrome) * History of chest computed tomogram or chest radiograph findings compatible with PAP * History of diagnosis of PAP made by at least one of the following methods: * Positive (Abnormal) serum GMAb test -OR- * Lung biopsy clearly documenting the presence of PAP of any type or degree -OR- * Bronchoalveolar lavage cytology compatible with PAP -OR- * Recessive or compound mutations in genes known to cause PAP, i.e. GM-CSF receptor α or β chain, GM-CSF, surfactant protein B or C or ABCA3, ABCG1, ABCA1, TTF1 Inclusion Criteria For Part B (Longitudinal \& PRO Survey Study of autoimmune PAP Patients) * Diagnosis of autoimmune PAP as indicated by: * Positive (Abnormal) Serum GMAb Test -AND- * History of chest CT or x-rays findings compatible with PAP -OR- * Lung biopsy clearly documenting the presence of PAP of any type or degree -OR- * Bronchoalveolar lavage cytology compatible with PAP Exclusion Criteria or Part A and Part B: * Individuals who have a serious medical illness that, in the opinion of the investigator, is likely to interfere with completion of the study will be excluded. For Part A (Cross-sectional Study of PAP Syndrome) * Individuals that do not have a diagnosis of PAP For Part B (Longitudinal \& PRO Survey Study of autoimmune PAP Patients) * Individuals that do not have a diagnosis of autoimmune PAP
Pulmonary Alveolar Proteinosis
Pulmonary Surfactant, Rare Lung Disease, Registry
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COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction

This study will demonstrate the safety and effectiveness of the Edwards Lifesciences SAPIEN 3/SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve (THV) Systems in subjects with a dysfunctional right ventricular outflow tract (RVOT) conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention.

Amy Pajk - amy.pajk@cchmc.org

ALL
NA
This study is NOT accepting healthy volunteers
NCT02744677
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Inclusion Criteria:

• Weight ≥ 20 kg (44 lbs.)
• Dysfunctional RVOT conduit or previously implanted valve in the pulmonic position with a clinical indication for intervention and with a landing zone diameter ≥ 16.5 mm and ≤ 29 mm immediately prior to study device insertion as per the Instructions for Use
• Subject presents with at least moderate PR and/or mean RVOT gradient ≥ 35 mmHg.
• The subject/subject's legally authorized representative has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.
Exclusion Criteria:

• Active infection requiring current antibiotic therapy (if temporary illness, subject may be a candidate 2 weeks after discontinuation of antibiotics)
• History of or active endocarditis (active treatment with antibiotics) within the past 180 days
• Leukopenia, anemia, thrombocytopenia or any known blood clotting disorder
• Inappropriate anatomy for femoral introduction and delivery of the study valve
• Need for concomitant atrial septal defect or ventricular septal defect closure or other concomitant interventional procedures other than pulmonary artery or branch pulmonary artery stenting or angioplasty
• Angiographic evidence of coronary artery compression that would result from transcatheter pulmonic valve implantation (TPVI)
• Interventional/surgical procedures within 30 days prior to the TPVI procedure.
• Any planned surgical, percutaneous coronary or peripheral procedure to be performed within the 30 day follow-up from the TPVI procedure.
• History of or current intravenous drug use
• Major or progressive non-cardiac disease resulting in a life expectancy of less than one year
• Known hypersensitivity to aspirin or heparin and cannot be treated with other antiplatelet and/or antithrombotic medications
• Known hypersensitivity to cobalt-chromium, nickel or contrast media that cannot be adequately premedicated
• Participating in another investigational drug or device study that has not reached its primary endpoint.
• Female who is lactating or pregnant
DEVICE: SAPIEN 3/SAPIEN 3 Ultra RESILIA THV, DEVICE: SAPIEN 3 THV, DEVICE: SAPIEN 3 Ultra RESILIA THV
Complex Congenital Heart Defect, Dysfunctional RVOT Conduit, Pulmonary Valve Insufficiency, Pulmonary Valve Degeneration
Tetralogy of Fallot, Aortic Valve Defect/Disease Resulting in Ross Procedure, Pulmonary Atresia, Pulmonary Stenosis, Truncus Arteriosus, Transposition of the Great Arteries, Transcatheter pulmonary valve implantation, Transcatheter pulmonary valve replacement, TPV, TPVR, TPVI
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Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients (CLAD)

The purpose of this study is to see if taking the study drug, Belumosudil, for 52 weeks in addition to your usual care and medication, will prevent Chronic Lung Allograft Dysfunction (CLAD) in participants who have a lung biopsy that shows evidence of rejection or inflammation to the transplanted lung(s). For this study, biopsies that show evidence of Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP) or Acute Lung Injury (ALI) are referred to as "Qualifying Biopsies"; patients who had evidence of one or more of these conditions on a recent biopsy are eligible for enrollment in this study. Belumosudil is an investigational drug that blocks a molecule in the body that reduces inflammation and scarring and may play a role in the development and progression of CLAD. Belumosudil is a drug approved by the FDA to treat adults and children 12 years and older with chronic graft-versus-host disease (cGVHD), a condition with some similarities to CLAD. The primary objective it to determine the efficacy of treatment with Belumosudil + maintenance immunosuppression (IS) versus placebo + maintenance IS on preventing the subsequent development of probable or definite CLAD, lung retransplant, or death.

Maryam Mysorewala - maryam.mysorewala@cchmc.org

ALL
12 years and over
PHASE2
This study is NOT accepting healthy volunteers
NCT06476132
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Inclusion Criteria:

• Participant and/or parent or guardian must be able to understand the purpose of the study, willing to participate, sign the informed consent, and if applicable assent.
• Single or bilateral lung transplant recipient age ≥ 12 years
• A qualifying biopsy obtained 60 to 760 days after lung transplant with evidence of allograft injury histology; a qualifying biopsy must have one or more of the following features alone or in combination: Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP), or Acute Lung Injury (ALI). The presence of any grade AR (A1 or greater) or LB (B1 or greater) qualifies for inclusion
• Females of reproductive potential and males with female partners of reproductive potential must agree to use effective contraception during treatment with belumosudil or placebo and for at least 3 months after the last dose. Participants must agree to refrain from donating or cryopreserving sperm, eggs (ova or ovocytes) for the purpose of reproduction during treatment with belumosudil or placebo and for at least 3 months after the last dose.
• Meeting hematologic laboratory criteria: absolute neutrophil count (ANC) \>= 0.5 x 10(9)/L and platelet count \>= 50 x 10(9)/L within 30 days of enrollment
• Meeting all blood chemistry laboratory criteria: aspartate aminotransferase (AST) or alanine transaminase (ALT) \< 2x upper limit of normal (ULN), bilirubin \< 1.5x ULN unless due to Gilbert's syndrome, estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 within 30 days of enrollment
• Cytomegalovirus (CMV) polymerase chain reaction (PCR) negative or, if detected, \<200 IU/ml in the absence of any signs of active infection, within 30 days of enrollment
• In the absence of contraindications, must have received adult vaccinations or documented immunity as outlined in current National Institute of Allergy and Infectious Diseases (NIAID) Division of Allergy, Immunology, and Transplantation (DAIT) Guidance for Patients in Transplant Trials
• Intent to receive calcineurin inhibitor (CNI)-based maintenance Immunosuppression (IS) regimen
Exclusion Criteria:

• Multi-organ transplants involving more than one organ type (e.g., heart-lung)
• Prior organ transplant or prior bone marrow transplant/hematopoietic stem cell transplantation
• Greater than 160 days after a qualifying biopsy
• Active AMR unless resolved and no treatments with prohibited medications for \> 90 days prior to enrollment
• Diagnosed with probable or definite CLAD according to International Society for Heart and Lung Transplantation (ISHLT) guidelines prior to enrollment.
• Posttransplant treatment with anti-thymocyte globulin within 30 days or alemtuzumab or any other prohibited medication within 90 days prior to enrollment.
• Epstein-Barr virus (EBV) seronegative recipient who received EBV positive donor lung(s).
• Treatment with any other investigational pharmacologic agent within 30 days prior to enrollment.
• Significant active uncontrolled infection which, in the opinion of the investigator, would place the participant at increased risk.
• Current use of sirolimus or everolimus.
• Recipient human immunodeficiency virus (HIV) positive.
• Recipient Hepatitis B surface antigen positive or Hepatitis B core antibody positive.
• Received lung(s) from a donor with known Hepatitis B virus (HBV) including Hepatitis B core antibody positive donors.
• Incompletely treated Hepatitis C (absence of ongoing treatment and post-transplant negative HCV PCR)
• History of clinically significant surgical factors (such as phrenic nerve damage, transplant lung resection, chest wall surgery), or mechanical factors (such as posttransplant airways disease including bronchial dehiscence, stenosis, dilation, or stent placement, pleural disease) that impedes lung function.
• Past or current medical problems, psychosocial concerns, or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose undue risk from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.
• Pregnant or breastfeeding
DRUG: Belumosudil, DRUG: Placebo for Belumosudil
Lung Transplant
Lung Transplant, Belumosudil, CLAD, Acute Rejection, Lymphocytic Bronchiolitis, Organizing Pneumonia, Acute Lung Injury
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SMART@Home Feasibility Trial

The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. Previous attempts have had poor clinical validity and suffered lack of patient engagement. The study team will deconstruct the previously implemented SMART platforms to create a roadmap, platform, and template to guide clinicians to create new tools. Results from Phase 1 of this project highlighted the need for connectivity between the SMART@Home app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making. A subsequent pilot user validation trial is also needed to confirm development goals were met. Conducting a pilot user validation trial of the SMART@Home asthma tracker, spirometer, and action plan is the purpose of the next phases of this study. A beta test the SMART@Home Asthma Tracker and asthma action plan algorithm will take place with approximately 8 participants. Beta testing will have participants record simulated increases in symptoms to ensure appropriate levels of care is communicated via the app. Then, a group of 40 adolescent (ages 12-17) patients with asthma for a 6-month pilot Randomized Control Trial (RCT). Participants will be randomized into either the IMAAP SMART@Home (n=20) or control (n=20) groups following the completion of baseline measures to test the interactive asthma action plan functionality and impact.

Jessica King - jessica.king1@cchmc.org

ALL
12 years to 18 years old
NA
This study is NOT accepting healthy volunteers
NCT06159127
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Inclusion Criteria:
* Patients diagnosed with a chronic medical condition requiring regular treatment, i.e., asthma * Ages 12-18 * English fluency for patient and caregiver
Exclusion Criteria:
* Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review * Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review
BEHAVIORAL: SMART@Home
Asthma, Asthma in Children
Asthma
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ES Catheter vs Cryoablation After Pectus Surgery

Participants will be randomized to receive ES catheter or cryoablation for pain management after the Nuss procedure. The goal of this study is to compare the following between the two groups: * Time to achieve short-term physical therapy goals and long-term functional outcomes * Compare immediate and long-term postoperative opioid use * Compare numbness on chest of postoperative day 1 and the return of sensation to baseline * Compare the incidence of neuropathic pain and other complications Participants will receive surveys for up to 12 months postoperatively.

Kristie Geisler - kristie.geisler@cchmc.org

ALL
12 years to 21 years old
NA
This study is NOT accepting healthy volunteers
NCT06682208
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Inclusion Criteria:
* Age 12 - 21 years * History of pectus excavatum * Scheduled for Nuss procedure
Exclusion Criteria:
* Prior pectus repair * Other concomitant surgeries * Chronic pain conditions including Ehlers Danlos Syndrome * Non-English speaking - rationale: the questionnaires used in the study are in English language and the social and cultural factors of pain perception of non-English speaking patients could affect the study power * Severe developmental delays including cognitive (difficulties understanding), motor (cerebral palsy or muscular dystrophy), and speech delays (difficulties communicating) * History of or active renal or liver disease * Major surgery requiring opioids in the last 2 years * Severe respiratory problems (such as obstructive sleep apnea, cystic fibrosis, pulmonary fibrosis, or pneumonia within the last month) * Cardiac conditions including, but not limited to, cyanotic heart disease, hypoplastic left ventricle, arrhythmia, uncontrolled hypertension with ongoing treatment, Kawasaki disease, or cardiomyopathies. Participants with asymptomatic valvular lesions or defects may be included * BMI \>35 * Pregnant or breastfeeding females
PROCEDURE: ES catheter, PROCEDURE: Intercostal nerve cryoablation (INC)
Pectus Excavatum
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The BRIDGE Pain Study (BRIDGE)

The purpose of the study is to discover at least two distinct Musculoskeletal pain subtypes. These types are caused by different brain-and-immune system signals that affect how the body feels pain, and they are also shaped by a person's biology, psychology, and social environment. Aim 1. We want to sort adolescents and young adults with long lasting muscle and bone pain into two different groups. To do this, we will look at participants' childhood medical histories, past treatments, when their pain started, the sex they were assigned at birth, what their pain feels like now, tests of how their body senses pain, and immune system markers found in their blood. We think we will find at least two different types of chronic pain groups, plus one group of patients who had a higher risk for pain (because of a rheumatic disease or past surgery) but never developed long term pain. Aim 2. We want to find out if certain patterns of inflammation in the body change how nerve cells react to pain. Aim 3: We want to understand how different biological, psychological, and social factors are connected to the chronic pain groups we identified. We think we will find certain mental, behavioral, and social risks-as well as protective factors-that help explain why some people develop long-lasting pain and others do not. We expect these factors to play different roles in each pain group, including the group that does not develop chronic pain.

Megan Kirschman - bridgestudy@cchmc.org

ALL
14 years to 26 years old
This study is NOT accepting healthy volunteers
NCT07602595
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Inclusion Criteria:
* Diagnosis of rheumatic/autoimmune disease/pain condition or surgery prior to age 18; Current age 14 to 26 years; Participant (and parent/legal guardian of participants \< 18 yo) can read and write in English; At least 1 year from diagnosis of pain or rheumatic disease; For individuals with MSK surgical history, at least 1 year after initial surgical intervention; For individuals with rheumatic disease, their disease must be considered inactive
Exclusion Criteria:
* They have active disease, or Other major medical comorbidities have developed after surgery following MSK surgical intervention.
OTHER: Not applicable- observational study
Juvenile Idiopathic Arthritis (JIA), Fibromyalgia, Lupus, Scoliosis, Pectus Excavatum, Chronic Pain, Musculoskeletal Pain
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A Phase 3 Trial to Compare IV BCV Versus IV CDV for Treatment of Adenovirus Infection After Allo-HCT (ENOVIA)

This randomized, open-label, parallel group, two-arm, multi-center assessment will compare IV BCV with IV CDV in adult and pediatric allogeneic HCT recipients with AdV viremia. A virologic response-driven approach to duration of treatment will be evaluated, in which randomized subjects are treated with either BCV or CDV until AdV viremia is confirmed as undetectable or until a maximum of 12 weeks of therapy, whichever occurs first. All subjects will be followed for a total of 24 weeks post-randomization, regardless of treatment assignment. Subjects will be assessed on a weekly basis through the end of treatment visit (EOT). Additional assessments will be performed at the test of cure (TOC) visit, which is 4 weeks after the last dose of study drug and at Weeks 12 and 24 post W1D1.

Brady Landon - brady.landon@cchmc.org

ALL
2 month(s) and over
PHASE3
This study is NOT accepting healthy volunteers
NCT07387367
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Inclusion Criteria:

• Male and female, post-allo HCT within last 180 days, aged 2 months and older at time of signing informed consent form.
• Subject/Guardian willing and able to understand and provide written informed consent to participate in the study.
• In the investigator's judgement, the subject's clinical condition justifies treatment with IV BCV or IV CDV for AdV infection.
• Has adenoviremia, based on any of: * AdV viremia DNA ≥10,000 IU/mL, OR * Two consecutive and rising AdV viremia DNA results of ≥1,000 IU/mL at screening, OR * AdV viremia DNA of ≥1,000 IU/mL, AND 1\. Lymphocyte count \<180/mm3, OR 2. Received T cell depletion, cord blood, or haploidentical transplant, OR 3. prior alemtuzumab, OR 4. anti-thymocyte globulin (ATG)
Exclusion Criteria:

• Subject received an allo-HCT with a matched sibling donor
• Subject received more than 5 mg/kg of CDV for any reason in the 21 days prior to first dose of study drug.
• Subject is allergic or hypersensitive to IV BCV or IV CDV or any of their components.
• Subject received anti-AdV-specific cell-based therapy within 3 weeks prior to W1D1 or an anti-AdV vaccine at any time.
• Subject has participated in any other investigational study within 30 days (or within 5.5 half-lives of the investigational product, whichever is longer) before signing the informed consent form (ICF), is currently participating in another interventional treatment trial with an investigational agent or is using an investigational device at the time of Screening.
DRUG: cidofovir, DRUG: Brincidofovir
Adenovirus Infections
Brincidofovir, Cidofovir, Adenovirus, allo-HCT, BCV-PA02, ENOVIA
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Multi-Center Molecular Diagnosis and Host Response of Respiratory Viral Infections in Pediatric Transplant Recipients

The participants are being asked to take part in this clinical trial, a type of research study, because the participants are scheduled to receive or have recently received a hematopoietic cell transplant (HCT) or a solid organ transplant (SOT). Primary Objective To determine if pre-transplant screening for respiratory viral load predicts RVI within 1- year post-transplant among survivors. Secondary Objectives: * To develop and validate a classifier based on pre-transplant immunological profile predictive of developing an acute respiratory viral infection (aRVI), with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors. * To develop and validate a classifier based on Day +100 post-transplant immunological profiles predictive of developing an acute respiratory viral infection (aRVI),with RSV/PIV3/HMPV/SARS-CoV-2 through one-year post-transplant among survivors .

Lara Danziger-Isakov, MD - Lara.Danziger-Isakov@cchmc.org

ALL
Up to 18 years old
This study is NOT accepting healthy volunteers
NCT05550298
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Recipient Inclusion Criteria * Less than 18 years at the time of anticipated transplant * Participant meets one of the following criteria:
• scheduled to receive allogeneic hematopoietic cell transplant within 14 days of enrollment or
• Scheduled to or received solid organ transplant within 7 days before or after enrollment * Participant is receiving care at the time of enrollment at one of the study participating institutions. * Parent/guardian willing and able to provide informed consent, and if appropriate, child willing and able to provide informed assent. Donor Inclusion Criteria * Donor for HCT recipient enrolled on the VIPER study. * Willing and able to provide informed consent.
Exclusion Criteria:
Recipient Exclusion Criteria None Donor Exclusion Criteria * Is not an HCT donor for a participant enrolled on the VIPER study. * Not available to provide pre-transplant research blood sample.
Hematopoietic Cell Transplant, Solid Organ Transplant, Respiratory Viral Infection
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Testing Drug Efficacy in Cystic Fibrosis Through N-of-1 Trials (Nof1)

The purpose of this study is to validate and utilize a personalized medicine approach to identify potential treatments with current FDA approved CFTR modifiers for non-approved CF gene mutations. The study will perform ex vivo testing of CFTR function and current marketed CFTR modulating drugs on expanded nasal cells at Cincinnati Children's Human Nasal Epithelium (HNE) Core Laboratory. The results will be confirmed and translated into bedside care through an N of 1 trial to determine effectiveness of treatment.

Sharon Kadon - sharon.kadon@cchmc.org

ALL
6 years and over
NA
This study is NOT accepting healthy volunteers
NCT04580368
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Inclusion Criteria:
* Signed informed consent (and assent when applicable) * Willing and able to adhere to the study visit schedule and protocol requirements * Male or Female ≥6 years old and within the FDA-approved range for the proposed modulator drug * Ivacaftor: ≥4 months old * Lumacaftor/Ivacaftor: 2 years old * Tezacaftor/Ivacaftor: 12 years old * Elexacaftor/Tezacaftor/Ivacaftor: ≥12 years old * At least one rare CFTR variant (incidence of \<5% of the CF population) * Documentation of a CF diagnosis as evidenced by one or more clinical features of CF plus at least one of the following: * Sweat Chloride ≥60mmol/L by quantitative pilocarpine iontophoresis * Two mutations in the CFTR gene * Abnormal nasal potential difference (NPD) testing supportive of a CF diagnosis * FEV1 \> 50% predicted for age * Stable chronic CF therapies with no changes in \>28 days (except for chronic cycled inhaled antibiotics such as tobramycin) * Prescribed CFTR modulator by a licensed physician * No contraindication to treatment with the selected drug at the time of treatment initiation
Exclusion Criteria:
* Presence of any condition or abnormality that, in the opinion of the Investigator, would compromise the safety of the patient and/or quality of the data * For women of child bearing potential: * Positive pregnancy test or known pregnancy at Visit 1 * Lactating * Unwilling to practice a medically acceptable form of contraception (acceptable forms include abstinence, hormonal birth control, intrauterine device, or barrier method plus a spermicidal agent), unless surgically sterilized or postmenopausal during the study * BMI \< 10th percentile for age (if \<18 years old) or \< 20kg/m2 (if ≥18 years old) * FEV1 ≤ 50% predicted for age * Growth of CF pathogens from sputum cultures that are associated with unstable disease (e.g., nontuberculous mycobacteria, Burkholderia spp) within six months of enrollment * Concomitant use of CYP3A inducers or inhibitors (e.g., voriconazole, fluconazole, rifampin) or prednisone (\>20mg daily) * Concomitant conditions: * Poorly controlled diabetes mellitus (HbA1c \>8.5 or glucosuria as noted below) * Advanced CF liver disease (cirrhosis with portal hypertension, ascites, or abnormal liver laboratory testing as noted below) * End stage renal disease * History of organ transplantation * Additional medical conditions that in the opinion of the Investigator place the patient at risk of participation or may impact the patient's ability to complete the trial (e.g., uncontrolled depression, anxiety disorder, poor adherence to CF therapies, active ABPA) * Any of the following abnormal laboratory values at the Screening Visit: * CBC * WBC \>15,000 K/mcL or ANC \<1,500 K/mcL * Hemoglobin \<10 gm/dL * Platelets \<50,000 K/mcL * Chemistries * \>2+ Glucosuria * Clinically significant abnormalities as assessed by the Investigator * Glomerular filtration rate ≤50 mL/min/1.73 m2 (calculated by the Counahan-Barratt equation) * Hepatic Function Testing / Coagulation Testing * ≥3 × upper limit of normal (ULN) aspartate aminotransferase (AST) * ≥3 × ULN alanine aminotransferase (ALT) * ≥3 × ULN gamma-glutamyl transpeptidase * Total or direct bilirubin \>2 × ULN * INR \> 1.5 x ULN * Positive pregnancy test
DRUG: CFTR Modulators
Cystic Fibrosis
CFTR modulators, cystic fibrosis, HNE, human nasal epithelial cells, NPD, nasal potential difference, air-liquid interface, N-of-1
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Dead Space and Inhaled Nitric Oxide in Pediatric Acute Respiratory Distress Syndrome (DiNO)

The goal of this observational study is to determine whether a marker of dead space (the end-tidal to alveolar dead space fraction \[AVDSf\]) is more strongly associated with mortality risk than markers of oxygenation abnormality (oxygenation index) and to determine whether dead space (AVDSf) is an important marker of heterogeneity in the inhaled nitric oxide (iNO) treatment effect for children with acute respiratory distress syndrome (ARDS). The study aims are: 1. To validate AVDSf for risk stratification of mortality in pediatric ARDS 2. To determine if there is heterogeneity in treatment effect for iNO defined by AVDSf 3. To detect the association between AVDSf and microvascular dysfunction trajectory and whether iNO therapy modifies this association This is a prospective, multicenter observational study of 1260 mechanically ventilated children with moderate to severe ARDS. In a subgroup of 450 children with severe ARDS, longitudinal blood samples will be obtained to measure plasma protein markers.

Abigayle Gibson - Abigayle.Gibson@cchmc.org

ALL
0 years to 21 years old
This study is NOT accepting healthy volunteers
NCT06690801
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Inclusion Criteria:
* Age \>37 weeks corrected gestational age to 21 years, including adults lacking the capacity to consent. * Within 72 hours of the start of invasive mechanical ventilation and meet the criteria for pediatric ARDS (new infiltrate on chest imaging and a known ARDS risk factor within 7 days of the onset of hypoxemia) and either meet criteria for moderate or severe pediatric ARDS between 4-72 hours of IMV (OI ≥ 8 or OSI ≥ 7.5) OR have an OI ≥ 20 or an OSI ≥ 14 x 15 minutes between 0-4 hours of IMV. * Subgroup of children eligible for longituduinal Blood Collection: Children with severe PARDS (OI ≥ 16 or an OSI ≥ 12 between 4-72 hours of IMV) or those with an OI ≥ 20 or an OSI ≥ 14 for 15 minutes between 0-4 hours of IMV will be eligible for collection of longitudinal plasma samples.
Exclusion Criteria:
* Non-conventional invasive mechanical ventilation (i.e. High Frequency Oscillatory Ventilation, Airway Pressure Release Ventilation) at the time of ICU admission * ECMO or iNO (or other inhaled pulmonary vasodilator therapy) at the time of ICU admission * Significant lower airways obstruction (examination of ventilator and capnography waveforms by site study or medical team) * Air leak \>20% (endotracheal tube, tracheostomy tube, or thoracostomy tube) * Home Invasive Mechanical Ventilation * Cyanotic Congenital Heart Disease * Previous enrollment in the DiNO study * Do not resuscitate order at the time of pediatric ARDS diagnosis. * Blood gas not obtained prior to initiation of ECMO, iNO, or non-conventional ventilation.
Acute Respiratory Distress Syndrome
Pediatrics, Mechanical Ventilation, Inhaled Nitric Oxide
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Safety and Efficacy of PMT Therapy of hPAP

The major goal of this study is to evaluate a new type of cell transplantation therapy for individuals with hereditary PAP, study a new treatment that may be useful for treatment of other diseases, and research mechanisms that drive the development and function of lung macrophages.

Brenna Carey - brenna.carey@cchmc.org

ALL
18 years and over
PHASE1
This study is NOT accepting healthy volunteers
NCT05761899
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Inclusion Criteria:
Patients must meet all of the following conditions to be eligible for participation in this study:
• Male or female with a confirmed diagnosis of hPAP defined as: * Homozygous or compound heterozygous CSF2RA mutations - AND - * A normal GM-CSF autoantibody test result - AND - * An abnormal STAT5-PI test result - OR - * An abnormal GM-CSF 50% effective concentration (EC50) test result
• Diffuse ground glass opacification of the lungs visualized on a chest computed tomogram (CT)
• History of prior receipt of WLL therapy or moderate hPAP lung disease severity requiring therapy in the opinion of the Clinical Site Investigator and/or Sponsor
• Able to undergo bone marrow collection by routine clinical aspiration
• 18 years of age or older on the date the Informed consent form (ICF) is signed
• Females who have been post-menopausal for \>2 years or females of child-bearing potential after a confirmed menstrual period using a highly efficient method of contraception (as described in Section 11.4.2) for the period from 3 months prior to the first administration of gene-corrected macrophages until 12 months after the last administration of gene-corrected macrophages. Females of child-bearing potential must have a negative serum pregnancy test at Screening (Visit 1), at bone marrow collection (Visit 2), and immediately before each administration of gene-corrected macrophages (Visits 3, 5, 7), and must not be lactating.
• Males of reproductive potential must agree to use condoms for the period from the 1st administration of gene-corrected macrophages until 12 months after the last dose of gene-corrected macrophages, have a partner who is not of child-bearing potential (i.e. men or females who have been post-menopausal for \>2 years), or have a female partner who is using adequate contraception as described in Section 11.4.2.
• Signed written informed consent form (ICF)
Exclusion Criteria:
Patients who meet any of the following conditions will not be eligible for participation in this study:
• History of a confirmed diagnosis of any other PAP-causing disease defined as:
• PAP caused by function-altering mutations in CSF2RB, adenosine triphosphate (ATP)-binding cassette subfamily A member 3 (ABCA3), SFTPB, SFTPC, Thyroid Transcription Factor 1 (TTF-1), GATA-binding factor 2 (GATA2), SLC7A7, and methionyl-transfer RNA (tRNA) synthetase (MARS), or other genes demonstrated to cause PAP other than CSF2RA
• PAP associated with an abnormal GM-CSF autoantibody test
• PAP associated with hematologic disorders including but not limited to myelodysplasia, aplastic anemia, leukemia, multiple myeloma, lymphoma
• PAP associated with non-hematologic malignancies
• PAP associated with immune deficiency syndromes
• PAP associated with chronic inflammatory syndromes
• PAP associated with chronic infections including but not limited to human immunodeficiency virus, Mycobacteria tuberculosis or other Mycobacterial species, or other organisms
• PAP associated with inhaled materials including but not limited to inorganic dusts (e.g., silica, titanium, indium, aluminum), organic dusts (e.g., sawdust, fertilizer); or gases/vapors (e.g., cleaning products, paints, and welding-related fumes)
• Pulmonary fibrosis that is clinically significant in the opinion of Clinical Site Investigator and/or Sponsor
• A confirmed (i.e., repeated) positive serum anti-GM-CSF receptor antibody test and/or a confirmed positive anti-lentiviral antibody test at the time of screening and prior to each administration of gene-corrected macrophages
• History of receipt of any investigational agent within 3 months of Study Visit 3
• History of active chronic infection (e.g., HIV, Hepatitis, others) at the time of Screening
• History of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Study Visit 3, defined as more than 14 drinks/week for females or 21 drinks/week for males (1 drink - 5 ounces (150 ml) of wine or 12 ounces (360 ml) of beer, or 1.5 ounces (45 ml) of hard liquor)
• History of medication or illicit drug abuse within 1 year prior to Study Visit 3, including but not limited to cocaine, heroin, or other opioids
• Currently or planning to become pregnant between the Screening visit and Visit 14 and/or currently breast-feeding
• Any other medical, behavioral, or psychiatric condition that would interfere with the completion of Study Visits or assessments in the opinion of the Clinical Site Investigator and/or Sponsor
COMBINATION_PRODUCT: Gene-Corrected Macrophages administered by bronchoscopic instillation
Hereditary Pulmonary Alveolar Proteinosis
Pulmonary Alveolar Proteinosis, Pulmonary Macrophage Transplantation
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Follow-up Automatically vs. As-Needed Comparison (FAAN-C) Trial (FAAN-C)

Compare the effectiveness of automatic vs as-needed (PRN) post-hospitalization follow-up for children who are hospitalized for common infections.

Holly Flake - Holly.Flake@cchmc.org

ALL
Up to 18 years old
NA
This study is NOT accepting healthy volunteers
NCT05471908
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Inclusion Criteria:
* Age \<18 years at the time of randomization * Hospitalization due to a primary diagnosis of pneumonia, skin and soft tissue infection, acute gastroenteritis, or urinary tract infection. * Parent speaks English or Spanish.
Exclusion Criteria:
* Presence of a comorbid disease that is both chronic and complex * Principal disease required surgical intervention (beyond superficial incision and drainage) * Immunodeficiency * A well-child check-up or post-hospitalization follow-up visit is already scheduled within 7 days of hospital discharge * Parent or participant strongly prefers PRN or automatic follow-up * A medical provider feels strongly that a post-hospitalization follow-up visit is needed within 7 days of hospital discharge * Sibling concurrently hospitalized * Unable to identify a clinic where the participant would receive any needed post-hospitalization follow-up * Diagnosis of pneumonia complicated by: o Receiving a chest tube * Diagnosis of urinary tract infection complicated by: * History of neurogenic bladder or urologic surgery * Renal imaging anticipated within 7 days of hospital discharge * Renal abscess * Diagnosis of skin and soft tissue infection complicated by: * Chronic wound * Postoperative infection * Predisposition to poor wound healing * Discharging with a drain in place * Complicated by necrotizing fasciitis or toxic shock syndrome * Diagnosis of gastroenteritis complicated by: * Hemolytic uremic syndrome
BEHAVIORAL: As-needed follow up, BEHAVIORAL: Automatic follow-up
Pneumonia, Urinary Tract Infections, Soft Tissue Infections, Gastroenteritis
post-hospitalization, follow-up care, patient centered care, randomized control trial
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Continued Pressure for Alveolar Protection (CPAP Trial) (CPAP)

The objective of the CPAP Trial is to test whether extending CPAP until 34 weeks' PMA or for at least 2 additional weeks compared to weaning to a nasal canula will decrease the likelihood of bronchopulmonary dysplasia or death at 36 weeks' PMA.

Traci Beiersdorfer - traci.beiersdorfer@cchmc.org

ALL
Up to 7 month(s) old
NA
This study is NOT accepting healthy volunteers
NCT07417111
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Inclusion Criteria:
* Gestational age \<29 weeks at birth * PMA \<32 weeks at study entry * On treatment with CPAP without a rate in FiO2 \<0.25 and PEEP of 4-5 cmH2O * Meet stability criteria: * If previously intubated must be extubated ≥ 72 hours * \<3 self-resolving apneas (≤ 20 s) and/or bradycardia (\<100 bpm) in any hour over previous 6 hours * No episodes of apnea or bradycardia requiring intervention (oxygen/stimulation/bag and mask) for 24 hours * Parents/legal guardians consent for enrollment
Exclusion Criteria:
* Major malformation * Neuromuscular condition that affects respiration * Terminal illness * Decision to withhold or limit support * Too sick to participate in opinion of Attending physician * Clinical shock, sepsis * Planned surgery during study period
DEVICE: CPAP, DEVICE: Nasal Cannula
Bronchopulmonary Dysplasia (BPD)
Continuous Positive Airway Pressure, CPAP
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Use of Hyperpolarized Xenon Gas for Lung Imaging in Children and Adults (HPXeMR)

The goal of this study is to evaluate the usefulness of hyperpolarized (HP) 129Xe (xenon) gas MRI for regional assessment of lung function in a normal population of children and adults and in adults and also in children with respiratory compromise due to a variety of diseases.

Carrie Stevens - Carrie.Stevens@cchmc.org

ALL
6 years and over
PHASE1
This study is also accepting healthy volunteers
NCT02272049
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Inclusion Criteria:
* Ages 6 and up * Participant must be able to hold breath for up to 16 seconds
Exclusion Criteria:
* History of heart defect * Pregnancy or positive pregnancy test * History of uncontrolled asthma defined for this study as requiring use of rescue inhaler ≥ 2 times in past month * Symptoms of respiratory infection (loose or productive cough or wheeze), chest tightness, or sinus infection within past week * Baseline oximetry at MRI visit of less than 95% on room air or less than 95% on a previously prescribed dosage of oxygen delivered by nasal cannula * Participant is claustrophobic and unable to tolerate the imaging. * Standard MRI exclusions (metal, implants)
DRUG: Hyperpolarized 129 Xenon
Respiratory Disorders
Respiratory
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MASA Valve Early Feasibility Study (MVEFS)

The MASA Valve Early Feasibility Study (MVEFS) multi-site interventional clinical trial within the United States of America with each center following a common protocol.The objective of the trial is to evaluate the safety and probable benefit of MASA Valve in the indicated subset of patients requiring Right Ventricular Outflow Tract Reconstruction (RVOTR). As an early feasibility study, the purpose is determine the feasibility of success of the device in order to gather early data towards a future pivotal study and/or regulatory clearance submission.

Joshua Freytag - Joshua.Freytag@cchmc.org

ALL
0 years to 22 years old
NA
This study is NOT accepting healthy volunteers
NCT05452720
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Inclusion Criteria:

• At least one of the following: Right Ventricular to Pulmonary Artery mean gradient \> 35mm Hg, moderate or severe Pulmonary regurgitation (≥3+), or clinical indication for replacement of their native or prosthetic pulmonary valve with a prosthesis.
• Age \< 22 years
• Patient is geographically stable and willing to return for 1 year follow-up for the trial.
• Patient's legal guardian should be willing to provide informed consent (IC) at the hospital location where they are being enrolled.
• The patient, and the patient's parent / legal representative where appropriate, and the treating physician agree that the subject will return for all required post-procedure follow up visits and the subject will comply with clinical investigation plan required follow-up visits.
Exclusion Criteria:

• Patient is in need of or has presence of a prosthetic heart valve at any other position
• Patient has a need for concomitant surgical procedures (non-cardiac)
• Patients with previously implanted pacemaker (including defibrillators) or mechanical valves
• Patient has an active bacterial or viral infection or requiring current antibiotic therapy (if temporary illness, patient may be a candidate 4 weeks after discontinuation of antibiotics)
• Patient has an active endocarditis
• Leukopenia, according to local laboratory evaluation of white blood cell count
• Acute or chronic anemia, according to local laboratory evaluation of hemoglobin Patients can be transfused to meet eligibility criteria
• Thrombocytopenia, defined as Platelet count \< 150,000/mm3 Patients can be transfused to meet eligibility criteria
• Severe chest wall deformity, which would preclude placement of the PV conduit
• Known hypersensitivity to anticoagulants and antiplatelet drugs and to the device materials
• Immunocompromised patient defined as: autoimmune disease, patients receiving immunosuppressant drugs or immune stimulant drugs
• Patient has chronic inflammatory / autoimmune disease
• Need for emergency cardiac or vascular surgery or intervention
• Major or progressive non-cardiac disease (liver failure, renal failure, cancer) that has a life expectancy of less than one year
• Currently participating, or participated within the last 30 days, in an investigational drug or device study
• Alcohol or drug abuse as defined by DSM IV-TR criteria for substance abuse - this includes the illicit use of cannabis within the last 12 months
• Patient has medical, social or psychosocial factors that, in the opinion of the Investigator, could have impact on safety or compliance
DEVICE: Surgical Right Ventricular Outflow Tract Reconstruction
Tetrology of Fallot, Pulmonary Stenosis, Truncus Arteriosus, Transposition of Great Vessels, Pulmonary Atresia, Ross Procedure
Right Ventricular Outflow Tract Reconstruction, Pulmonary Valve, MASA Valve, Pulmonary Valve Replacement
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Biomarker and Renal Angina Validation to Assess Heart-Kidney Outcomes After Amino Acid Therapy (BRAVE-HEART)

The goal of the BRAVE-HEART study is to learn if an amino acid infusion can reduce the risk of developing acute kidney injury after cardiac surgery in children. The main questions it aims to answer are: 1. Does an amino acid infusion decrease the number of participants with acute kidney injury? 2. Does an amino acid infusion decrease the number of days that participants are on a ventilator after cardiac surgery? Researchers will compare amino acids to a placebo (a look-alike substance that contains no drug) to see if amino acids decrease the number of participants with acute kidney injury. Participants will receive an amino acid or placebo infusion for up to 72 hours starting during cardiac surgery and only while in the operating room or the intensive care unit.

Kelli Krallman, RN, BSN, MS - kelli.krallman@cchmc.org

ALL
Up to 18 years old
PHASE2
This study is NOT accepting healthy volunteers
NCT07212595
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Inclusion Criteria:
* Expected to be at high risk of developing acute kidney injury after cardiac surgery based on Age, The Society of Thoracic Surgeons-European Association for Cardio-Thoracic Surgery (STAT) score, and anticipated cardiopulmonary bypass time * Age less than or equal to 18 years * Weight greater than or equal to 5 kilograms
Exclusion Criteria:
* Preoperative extracorporeal organ support * History of chronic kidney disease * Known or suspected inborn errors of amino acid metabolism * Known hypersensitivity to amino acids * Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) \> 3 times the upper limit of normal for age/gender * Preterm infants less than 6 months of age who were born at less than 36 weeks gestational age * Anuria at the time of randomization * Expected use of total parental nutrition (TPN) within the first 72 hours post-operatively
DRUG: Amino Acid infusion, DRUG: Lactated ringers solution
Acute Kidney Injury, Mechanical Ventilation
Cardiac Bypass, Pediatric, Acute Kidney Injury, Amino Acids
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