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CorMatrix Cor TRICUSPID ECM Valve Replacement Study
Isabella Aspromonte - Isabella.Aspromonte@cchmc.org
ALL
1 year to 85 years old
NA
NCT02397668
Inclusion Criteria:
• Patient with a regurgitant or absent tricuspid valve requiring surgical treatment including those patients having concomitant cardiac procedures
• Male or female
• Patient/authorized legal guardian understands the nature of the procedure, is willing to comply with associated follow-up evaluations, and provides written informed consent and the pediatric patient (if applicable) provides written assent (if able) prior to procedure
• Patient/patient's authorized legal guardian is geographically stable (or willing to return for required study follow-up) and understands and is willing to fulfill all of the expected requirements of this clinical protocol
• Children with congenital disease where the Cor PEDIATRIC Tricuspid ECM Valve would be the physiological right-sided valve
Exclusion Criteria:
• Tricuspid annulus too small (\< 10mm) to accommodate the Cor Tricuspid ECM Valve
• Left ventricular ejection fraction (LVEF) \< 25%
• Mean pulmonary pressure \> 50mm Hg or pulmonary vascular resistance greater than 6 Woods Units
• Emergency cardiac procedure. An example would be a person requiring resuscitation and in cardiogenic shock. An unscheduled or unplanned emergency surgery
• Cardiac transplant patient
• Acute transmural myocardial infarction (MI) within 7 days of enrollment that results in cardiogenic shock
• Patients with a single ventricle where the Cor Tricuspid ECM Valve would be the systemic AV valve
• Documented primary coagulopathy or uncorrected platelet disorder, including thrombocytopenia (absolute platelet count \<30k). Patient can be enrolled regardless of these parameters if in the opinion of the Investigating Surgeon the coagulopathy can be adequately reversed by transfusions. An example would be the reversal of thrombocytopenia by transfusion of platelets
• Documented evidence of intrinsic hepatic disease (defined as liver enzyme values (aspartate aminotransferase (AST), alanine aminotransferase (ALT), or total bilirubin) that are \> 5 times the upper limit of reference range within 30 days of enrollment, except in association with acute/reversible decompensation as determined by the Investigator)
• Documented evidence of significant renal dysfunction (serum creatinine \> 4.0mg/dl or GFR\< 30 on the modified Schwartz formula)
• Stroke within 30 days prior to enrollment
• Major or progressive non-cardiac disease (liver failure, renal failure, cancer (CA)) that has a life expectancy of less than one year
• Known cancer (cancer-free \<1 year; does not include non-metastatic basal cell carcinoma or cervical carcinoma) and/or undergoing treatment including chemotherapy and radiotherapy
• Hematological disorders (e.g., aplastic anemia) or patients taking bone marrow suppressant drugs
• Known sensitivity to porcine materials
• Contraindication to anticoagulation/antiplatelet therapy (aspirin (ASA) and/or Plavix)
• Patients who are pregnant (method of assessment Investigator's discretion)
• Patients who are currently enrolled in another investigational study or registry that would directly impact the treatment or outcome of the current study, without CorMatrix written approval
DEVICE: CorMatrix Cor TRICUSPID ECM Valve
Tricuspid Valve Disease
Use of Hyperpolarized 129Xe MR Lung Imaging in Adults for Calibration (HpXeMRCal)
- jason.woods@cchmc.org
ALL
18 years and over
PHASE1
NCT02316379
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
A Study of Emapalumab for Pediatric Aplastic Anemia
Anthony Sabulski, MD - anthony.sabulski@cchmc.org
ALL
0 years to 25 years old
PHASE2
NCT06430788
Inclusion Criteria:
* Patients undergoing workup for suspected newly diagnosed sAA:
* Patients with severe cytopenias and a hypocellular marrow concerning for sAA
* Patients that meet the definition for suspected sAA (Camitta Criteria) as follows:
Marrow Cellularity: \<25%, or 25-50% with \<30% residual hematopoietic cells Peripheral cytopenias (at least 2 of 3) Absolute neutrophil count (ANC): \<500 x 10\^9/L Platelets: \<20 x 10\^9/L Absolute Reticulocyte Count: \<60 x 10\^9/L
* Patients that do not have evidence of leukemia or MDS
* Patients \< 25 years of age at time of diagnosis
* Able to tolerate emapalumab and IST (with standard institutional organ function criteria)
Exclusion Criteria:
* Uncontrolled infection at presentation.
* Patients who have undergone previous treatment for sAA.
* Patients with known inherited bone marrow failure
* Patient who has completed a full workup for sAA including having results back from telomere testing, DEB and genetics (when applicable), as well as having an appropriate willing and available donor and would otherwise be admitted for HSCT within 2 weeks of enrolling on the trial
* Patients with leukemia or MDS
* Patient or parent or guardian unable to give informed consent or unable to comply with the treatment protocol including research tests. BIOLOGICAL: Emapalumab
Aplastic Anemia, Cytopenia, Hypocellular Marrow
pediatric aplastic anemia, aplastic anemia, cytopenia, hypocellular marrow, Emapalumab, Memorial Sloan Kettering Cancer Center, 23-278
Speech-in-noise Perception in Autism and Fragile X
Elizabeth Smith - elizabeth.smith3@cchmc.org
ALL
15 years to 35 years old
NA
NCT06088589
Inclusion Criteria:
• normal audiograms (PTA ≤ 20 dB HL)
• corrected 20/20 vision (Snellen chart)
• no history of premature birth (prior to 36 weeks gestation)
• no medications known to affect EEG signal
• English as the first language Inclusion for the Autism group requires the following: 1\) diagnosis of Autism Spectrum Disorder either based on previous ADOS administration and developmental history, or confirmed via ADOS and developmental history Inclusion for the Autism + FXS group requires the following:
• Documented PCR/Southern Blot genetic testing confirming full mutation FXS
• Diagnosis of Autism Spectrum Disorder, per Autism group. Inclusion for the Typically Developing group requires the following:
• no siblings or parents with an Autism Spectrum Disorder or Fragile X Syndrome
• no current neurological or psychiatric diagnoses
• IQ over 75
Exclusion Criteria:
* Hearing loss or uncorrected vision loss
* history of premature birth (prior to 36 weeks gestation) BEHAVIORAL: Mismatch negativity
Autism Spectrum Disorder, Fragile X Syndrome
Feto-Endoscopic Tracheal Occlusion (FETO) for Severe Congenital Diaphragmatic Hernia (FETO)
Sandi Bechtol - sandra.bechtol@cchmc.org
FEMALE
18 years to 50 years old
NA
NCT02986087
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
Registry of Asthma Characterization and Recruitment 3 (RACR3) (RACR3)
Kathryn Geil - kathryn.geil@cchmc.org
ALL
NCT05272241
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
RASopathy Biorepository
Lindsey Aschbacher-Smith - lindsey.aschbacher-smith@cchmc.org
ALL
NCT04395495
Inclusion Criteria:
* Patients with a suspected or known diagnosis of any of the group of disorders known as RASopathies (e.g., Neurofibromatosis, Costello Syndrome, Noonan Syndrome). Diagnosis may be made clinically and/or confirmed through genetic testing.
* Unaffected relatives of patients with a suspected or known diagnosis of any of the group of disorders known as RASopathies.
Exclusion Criteria:
* Individuals who do not have a suspected or definite diagnosis of a RASopathy.
* Individuals who do not have a relative with a suspected or definite diagnosis of a RASopathy.
* Patients who do not have the ability/capacity to undergo the informed consent process OR whose parent/legal guardian is unable to undergo the informed consent process. RAS Mutation, Neurofibromatosis 1, Noonan Syndrome, Noonan Syndrome With Multiple Lentigines, Noonan Neurofibromatosis Syndrome, Cardiofaciocutaneous Syndrome, Costello Syndrome, Legius Syndrome, Smith-Kingsmore Syndrome, MTOR Gene Mutation, GATOR-1 Gene Mutation, SYNGAP1-Related Intellectual Disability, DLG4, MAPK1 Gene Mutation
Development and Validation of Patient Reported Outcome (PRO) Measures for Individuals With Neurofibromatosis 1 (NF1) and Plexiform Neurofibromas (pNFs)
cancer@cchmc.org
ALL
5 years and over
NCT02544022
* SUBJECT INCLUSION CRITERIA:
* Documented NF1 either by NIH clinical criteria or molecularly-proven mutation in the
NF1 gene, PER the Neurofibromatosis Diagnostic Criteria AND \>=1 plexiform neurofibroma in any location that is either symptomatic or asymptomatic, and is defined by the following:
• a neurofibroma that has grown along the length of a nerve and may involve multiple fascicles and branches OR a spinal neurofibroma that involves two or more levels with connection between the levels or extending laterally along the nerve OR a skin thickness neurofibroma;
• measures \>=3 cm on longest diameter by visual exam, palpation or 2D MR imaging OR \>=3 mL by volumetric MR imaging. * For phase 1, Age \>=5 years. (complete) * For phase 2, Age \>= 8 years * Ability of subject or parent or guardian to understand and the willingness to sign a written informed consent document. * Participants must be able to understand, read, and speak the English language. * For phase 1 focus groups only, patients need to report experiencing pNF related pain recently with a minimum pain level of 3 on the current NRS-11 or report taking prescription medication that reduces pain and experiencing pNF related pain recently with a minimum pain level of 1 on the current NRS-11. (complete) * For phase 2 patients with pain, patients need to report recently experiencing at least a minimal amount of pNF-related pain. Specifically, they will be asked if they recently experienced any pain in a target tumor area and will have to respond yes to be eligible. * For phase 2 patients without pain, patients need to report no recent pNF-related pain. Specifically, they will be asked if they recently experienced any pain in a target tumor area and will have to respond no to be eligible. PRIMARY CAREGIVER INCLUSION CRITERIA: * Primary caregiver (i.e. parent,guardian, grandparent) who is \>= 18 years old of participating subject \<= 17 years old * Participants must be able to understand, read, and speak the English language EXCLUSION CRITERIA: * Patients with severe cognitive or behavior impairments who, in the judgment of the investigators, would not be able to cooperate with the study procedures will be excluded. * Patients cannot be newly enrolled on a clinical trial to treat their pNF or cannot have started a new pain treatment regimen (e.g., medication, psychosocial therapy, physical therapy, etc.) at the time of enrollment. Specifically, patients will be ineligible if they were enrolled on a MEK inhibitor trial in the past 12 months or began a new pain medication or treatment within the past 3 months prior to enrollment on this study.
• a neurofibroma that has grown along the length of a nerve and may involve multiple fascicles and branches OR a spinal neurofibroma that involves two or more levels with connection between the levels or extending laterally along the nerve OR a skin thickness neurofibroma;
• measures \>=3 cm on longest diameter by visual exam, palpation or 2D MR imaging OR \>=3 mL by volumetric MR imaging. * For phase 1, Age \>=5 years. (complete) * For phase 2, Age \>= 8 years * Ability of subject or parent or guardian to understand and the willingness to sign a written informed consent document. * Participants must be able to understand, read, and speak the English language. * For phase 1 focus groups only, patients need to report experiencing pNF related pain recently with a minimum pain level of 3 on the current NRS-11 or report taking prescription medication that reduces pain and experiencing pNF related pain recently with a minimum pain level of 1 on the current NRS-11. (complete) * For phase 2 patients with pain, patients need to report recently experiencing at least a minimal amount of pNF-related pain. Specifically, they will be asked if they recently experienced any pain in a target tumor area and will have to respond yes to be eligible. * For phase 2 patients without pain, patients need to report no recent pNF-related pain. Specifically, they will be asked if they recently experienced any pain in a target tumor area and will have to respond no to be eligible. PRIMARY CAREGIVER INCLUSION CRITERIA: * Primary caregiver (i.e. parent,guardian, grandparent) who is \>= 18 years old of participating subject \<= 17 years old * Participants must be able to understand, read, and speak the English language EXCLUSION CRITERIA: * Patients with severe cognitive or behavior impairments who, in the judgment of the investigators, would not be able to cooperate with the study procedures will be excluded. * Patients cannot be newly enrolled on a clinical trial to treat their pNF or cannot have started a new pain treatment regimen (e.g., medication, psychosocial therapy, physical therapy, etc.) at the time of enrollment. Specifically, patients will be ineligible if they were enrolled on a MEK inhibitor trial in the past 12 months or began a new pain medication or treatment within the past 3 months prior to enrollment on this study.
Neurofibromatosis 1, Plexiform Neurofibromas
Pain Scale, QOL, Tool Validation, Cognitive Interviews, Natural History
Safety and Efficacy of FETO in CDH Phase III (CDH FETO)
Foong-Yen Lim - foong.yen.lim@cchmc.org
FEMALE
18 years to 50 years old
PHASE3
NCT07187206
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
Diaphragmatic Hernia Research & Exploration, Advancing Molecular Science (DHREAMS)
Trish Burns - trish.burns@cchmc.org
ALL
NCT00950118
Inclusion Criteria:
* All individuals affected with a congenital diaphragmatic hernia (CDH), or with a family history of a CDH
Exclusion Criteria:
* Individuals with no personal history of a CDH or family history of a family member affected with congenital diaphragmatic hernia Congenital Diaphragmatic Hernia
Congenital Diaphragmatic Hernia (CDH), Genes, Genetic, Genetic testing, exome sequencing, genome sequencing, RNAseq
Data and Sample Collection Study to Elucidate the Mechanisms of Eosinophilic Disorders
Bliss Magella - bliss.magella@cchmc.org
ALL
NCT00267501
Inclusion Criteria:
* Signed informed consent obtained from the patient or parent/guardian. Assent will be obtained from all minors 11 years of age and older.
* Carrying a diagnosis of eosinophilic gastrointestinal disease, eosinophilic inflammatory disease, or food allergy OR family member, or normal control Eosinophilic Gastrointestinal Disease Eosinophilic Inflammatory Disease, Food Allergy
Eosinophilic Disorders
The Congenital Dyserythropoietic Anemia Registry (CDAR)
Theodosia Kalfa - theodosia.kalfa@cchmc.org
ALL
NCT02964494
Inclusion Criteria:
* Diagnosis of Congenital Dyserythropoietic Anemia (CDA), whether a genetic mutation is identified or not
* Evidence of congenital anemia/jaundice or a positive family history
* Evidence of ineffective erythropoiesis
* Typical morphological appearance of bone marrow erythroblasts
* All ages (ages 0-99)
Exclusion Criteria:
* Diagnosis of cancer
* Myelodysplasia
* Secondary dyserythropoiesis: e.g.; vitamin B12 deficiency or drug-related.
Note1: Patients with rare band 3 (SLC4A1) mutations recently described to be associated with dyserythropoiesis will be eligible since the mechanisms appear to involve direct participation of band 3 in the erythroblast mitosis and cytokinesis.
Note2: Siblings, parents, and family members of patients with confirmed CDA diagnosis are encouraged to participate in the study. Congenital Dyserythropoietic Anemia (CDA)
Food-based Support for Hospitalized Children and Their Families (FRESH)
Kathy Auger - katherine.auger@cchmc.org
ALL
Up to 21 years old
NA
NCT06946355
Inclusion Criteria:
* All families of patients less than 21 years of age with Medicaid insurance or uninsured will be eligible
Exclusion Criteria:
* Patients admitted for end-of-life care, patients who will be discharged to a location other than home, patients who live independently, and patients in county custody. OTHER: In-hospital food support intervention, OTHER: Post-discharge food support intervention
Food Insecurity
Pediatric, Hospitalization, Food Intake
Health-E You Efficacy Trial for Male Adolescents
Emmanuel Chandler - emmanuel.chandler@cchmc.org
MALE
13 years to 21 years old
NA
NCT06525064
Inclusion Criteria:
* Assigned male sex at birth
* Age 13 to 21 years old
* English and/or Spanish as preferred language to read, listen, and converse
* Self-reported engagement in vaginal and/or anal sex in the past 12 months
* Access to phone or internet for follow-up study activities
Exclusion Criteria:
* Aged 12 or younger or older than 21
* Primary language other than English or Spanish
* Not able to provide informed consent
* Unable to communicate due to cognitive, mental, language, or other difficulties
* Not sexually active, engaged in oral sex only, or more than 12 months have passed since last vaginal and/or anal sex.
* Previous participation in a Health-E You study activity or the app OTHER: Health-E You app
Sexually Transmitted Diseases, Sexual Health, Reproductive Health
male adolescent, condom use, mhealth
Overlapping Pain Trajectory Study (COPC)
Catherine Jackson - catherine.jackson@cchmc.org
ALL
10 years to 19 years old
NCT05752396
Inclusion Criteria:
• General Criteria * Access to the internet either by laptop, tablet, or phone (for REDCap Surveys) * English-speaking * Parent or guardian willing to comply with protocol, complete study assessments, and provide written informed consent
• Control Specific Criteria * No history/active chronic pain
• Patient Specific Criteria * Patients will need a diagnosis of a chronic pain derived congruent with ICD-11 criteria related to headache (migraine, daily headache), abdominal (FAPD), localized MSK (single limb/joint, low back or chest pain), or diffuse MSK (widespread MSK pain) * If on medications, they need to be on stable doses of prescribed pain and/or psychiatric medications for 4 weeks before the baseline study visit.
Exclusion Criteria:
• General Criteria * Skin conditions (e.g., eczema) or past skin damage on the arms and legs in or near sites of sensory testing * Any comorbid rheumatic disease (e.g., arthritis, lupus), neurological (e.g., epilepsy, traumatic brain injury) or medical condition (e.g., cancer, diabetes)
• Control Specific Criteria * Taking medications that can alter pain sensitivity (e.g., NSAIDs, opioids, stimulants, anticonvulsants; psychiatric)
• Patient Specific Criteria * Present psychiatric disease as defined by DSM IV (e.g. psychosis, bipolar disorder, major depression, generalized anxiety disorder), alcohol or drug dependence, or documented developmental delays or impairments (e.g., autism, cerebral palsy, ADHD, or mental retardation) that, in the opinion of the investigator, would interfere with adherence to study requirements or safe participation in the study
OTHER: Conditioned Pain Modulation, OTHER: Offset Analgesia, OTHER: Spatial Summation, OTHER: Temporal Summation
Migraine, Musculoskeletal Pain, Functional Abdominal Pain Disorders, Chronic Pain, Widespread Chronic Pain, Low Back Pain, Healthy Volunteers
Neonatal Platelet Transfusion Threshold Trial (NeoPlaTT)
Traci Beiersdorfer - traci.beiersdorfer@cchmc.org
ALL
1 hour to 48 hours old
NA
NCT06676904
Inclusion Criteria:
* Gestational age of 23 0/7 to 26 6/7 weeks
* Postnatal age of \< 48 hours
Exclusion Criteria:
* Comfort care or withdrawal of care planned
* Neonatal alloimmune thrombocytopenia or suspected/confirmed congenital platelet or bleeding disorder
* Receipt of platelet transfusion
* No receipt of Vitamin K
* Parents/guardian decline consent PROCEDURE: Higher Platelet Transfusion Threshold, PROCEDURE: Lower Platelet Transfusion Threshold
Thrombocytopenia, Neonatal, Platelet Transfusion, Infant, Newborn, Diseases, Infant, Extremely Low Birth Weight, Infant, Small for Gestational Age, Thrombosis
platelet transfusion, neonatal, thrombosis
Chicago Parent Program for Foster and Kinship Caregivers
Laura Fossett - laura.fossett@cchmc.org
ALL
2 years and over
NA
NCT06170047
Inclusion Criteria:
* Must be a licensed foster caregiver or kinship caregiver to a foster child between the ages of 2 and less than 9 years of age
* Must be a licensed foster caregiver or kinship caregiver to a foster child in Ohio and in the custody of Hamilton County Job and Family Services, Butler County Children Services, or Montgomery County Children Services
* Must be in good standing with the foster care agency
* Must be English-speaking
Exclusion Criteria:
* Not having a foster child between the ages of 2 and less than 9 years
* The foster child not being in the custody of Ohio counties: Hamilton County Job and Family Services, Butler County Children Services, or Montgomery County Children Services
* The foster child was placed in the home more than 45 days prior to enrollment
* The foster child being moved out of the placement prior to the start of the intervention
* The foster child having been previously enrolled with another caregiver
* The caregiver having been previously enrolled with another child
* The caregiver unable to commit to completing all study activities
* The foster child is not enrolled in the study BEHAVIORAL: Chicago Parent Program for Foster Care, OTHER: Usual Care
Behavior Problem, Parenting
Foster care, Child behavior, Parenting skills, Behavioral health, Prevention, Parenting confidence, Parenting stress
A Phase 3 Study of Revaccination in Subsequent Pregnancies With Bivalent RSV Vaccine and Duration of Protection of a Single Dose
Benjamin Kercsmar - Benjamin.Kercsmar@cchmc.org
ALL
Not specified
PHASE3
NCT06866405
Pregnant Participants-Cohort 1 and Cohort 2 Key Inclusion Criteria
* Women aged 18 to 49 who are pregnant, between 24 and 36 weeks along, and expecting one baby without known risks for complications can participate.
* Had the RSVpreF or Abrysvo vaccine during a previous pregnancy.
* Had an ultrasound scan at 18 weeks or later during their current pregnancy, with no major fetal problems detected.
* Based on their medical history, physical check-up, and the doctor's judgment, they are found suitable to join the study.
* Agrees to let their baby take part in the study and gives their permission.
* Able to sign a consent form, agreeing to follow the rules and conditions of the study.
Key Exclusion Criteria
* Received any approved or experimental RSV vaccine since their previous pregnancy.
* Has a pre-pregnancy body mass index (BMI) over 40 kg/m2.
* History of a severe bad reaction to a vaccine or a serious allergic reaction (like anaphylaxis) to any ingredient in the study vaccine or a similar vaccine.
* Current pregnancy problems or issues at the time of giving consent.
* Previous pregnancy issues or problems at the time of giving consent.
* Women who are breastfeeding at the time of enrollment
Infant Participants
* Proof that the parent(s) or legal guardian(s) has signed and dated a consent form.
* Parent(s) or legal guardian(s) must agree to attend scheduled visits and follow the study plan, including laboratory tests and other procedures.
Nonpregnant Participants-Cohort 3 Key Inclusion Criteria
* Have already received one dose of the RSVpreF vaccine during their previous pregnancy as part of the Pfizer clinical trial, and the results from that time can be used for this study.
* Able to sign a consent form, agreeing to follow the rules and requirements of the study.
Key Exclusion Criteria
* Received any approved or experimental RSV vaccine after participating in the Pfizer clinical trial.
* Taking part in other studies with new drugs within 28 days before giving consent or during the study period.
BIOLOGICAL: RSVpreF, BIOLOGICAL: Placebo
RSV Infection
Pregnancy, RSV vaccine, RSV, Maternal immunization
BSGM to Evaluate Patients With GI Symptoms
Khalil El-Chammas, MD - Khalil.El-Chammas@cchmc.org
ALL
8 years to 25 years old
NCT05880199
Inclusion Criteria for Cases
• Males or females age 8 to 25 years.
• Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
• Confirmed diagnosis of a Functional Gastrointestinal and/or Motility Disorder OR undergoing one of the following procedures as part of their clinical care at one of the participating centers:
• HRVB
• PENFS
• ADM
• Colonic Manometry
• Pyloric Botox
• Pyloric Dilation
• Gastric Scintigraphy
• GES
• gammaCore
• Those with a body mass index of \< 35.
• Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria for Cases
• History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin. (Please note, majority of feeding tubes can be accommodated by the array placement.)
• Pregnant women.
• Those with any condition, where fasting is not recommended by a physician.
• Any allergies to foods that may be present in the standardized meal that cannot be accommodated with an acceptable substitute meal.
• Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration.
• Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
• Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.
• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. Inclusion Criteria for Controls
• Males or females age 8 to 25 years.
• Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
• Do not have an active Functional Gastrointestinal disorder (FGID) diagnosis and will not be undergoing any procedures outlined in the recruitment plan in the near future.
• Those with a body mass index of \< 35.
• Individuals may include siblings of those with FGIDs.
• Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria for Controls
• History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin.
• Pregnant women.
• Those with any condition, where fasting is not recommended by a physician.
• Allergies to foods that may be included in the standardized meal that cannot be accommodated with an acceptable substitute meal.
• Those with physical limitations, who are not able to maintain a relaxed reclined position for the study duration.
• Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
• Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.
• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
• Males or females age 8 to 25 years.
• Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
• Confirmed diagnosis of a Functional Gastrointestinal and/or Motility Disorder OR undergoing one of the following procedures as part of their clinical care at one of the participating centers:
• HRVB
• PENFS
• ADM
• Colonic Manometry
• Pyloric Botox
• Pyloric Dilation
• Gastric Scintigraphy
• GES
• gammaCore
• Those with a body mass index of \< 35.
• Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria for Cases
• History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin. (Please note, majority of feeding tubes can be accommodated by the array placement.)
• Pregnant women.
• Those with any condition, where fasting is not recommended by a physician.
• Any allergies to foods that may be present in the standardized meal that cannot be accommodated with an acceptable substitute meal.
• Those with physical limitations, who are not able to maintain a relaxed reclined position for the study visit duration.
• Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
• Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.
• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. Inclusion Criteria for Controls
• Males or females age 8 to 25 years.
• Females ≥11 years of age or who have reached menarche must have a negative urine pregnancy test.
• Do not have an active Functional Gastrointestinal disorder (FGID) diagnosis and will not be undergoing any procedures outlined in the recruitment plan in the near future.
• Those with a body mass index of \< 35.
• Individuals may include siblings of those with FGIDs.
• Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria for Controls
• History of skin allergies or a history of extreme sensitivity to cosmetics or lotions. Currently open wounds, abrasions, infected or inflamed abdominal skin.
• Pregnant women.
• Those with any condition, where fasting is not recommended by a physician.
• Allergies to foods that may be included in the standardized meal that cannot be accommodated with an acceptable substitute meal.
• Those with physical limitations, who are not able to maintain a relaxed reclined position for the study duration.
• Those with major developmental delay or cognitive impairment, who are not able to report their symptoms/feelings in the questionnaires.
• Those with GI motility disorders that are limited in the esophagus, and the gastric mapping is restricted to capture relevant data based on the investigator's discretion.
• Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
DEVICE: Body surface gastric mapping device
Gastrointestinal Motility Disorders in Children, Functional Gastrointestinal Disorders, Gastroparesis, Dyspepsia and Other Specified Disorders of Function of Stomach
GI motility, gastroparesis, functional dyspepsia
Thebaine Urine Testing
Holly Flake - holly.flake@cchmc.org
ALL
18 years to 65 years old
NCT07192887
Inclusion Criteria:
* Male or female
* Ages 18-65
* Healthy
Exclusion Criteria:
* Allergy to poppy seeds, or any of the related food stuffs used in the study
* Celiac disease or gluten sensitivity
* Ongoing or opioid use in the past 6 months
* History of renal or hepatic disease or dysfunction
* Inability or unwillingness to give repeated urine specimens
* Unwillingness to refrain from eating poppy seed-containing products during the two-day course of the study
* Non-English speakers (due to study materials being in English)
* BMI greater than 30
* Antibiotic use in the previous 2 months
* Recent ingestion of poppy seeds from the previous 7 days Urine Specimen Collection
Use of Hyperpolarized Xenon Gas for Lung Imaging in Children and Adults (HPXeMR)
Carrie Stevens - Carrie.Stevens@cchmc.org
ALL
6 years and over
PHASE1
NCT02272049
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
Suicide Treatment Alternatives for Teens (START)
Katelyn Armstrong - katelyn.armstrong@cchmc.org
ALL
12 years to 18 years old
NA
NCT04089254
Inclusion Criteria:
• Adolescents that are 12 through 17 years old (including 17 year olds who will turn 18 years old during the course of the study).
• Are brought to the Emergency Department (ED) due to suicidal thoughts or behaviors
• Require a higher level of care (OCIC or Inpatient) indicated by clinician determination and a CHRT-SR score of 15 to 52.
• The presence of a legal guardian
• Capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
Exclusion Criteria:
• Adolescents with suicidal thoughts that place themselves at a serious imminent risk of suicide based on clinical judgment.
• Adolescents who require 24 hour/day supervision but no adult can provide 24 hour/day supervision outside of the hospital
• Adolescents without the ability to read and answer survey questions
• Adolescents that are non-English speaking due to the scales and surveys that are used for this study only being available in English.
BEHAVIORAL: Inpatient Psychiatry, BEHAVIORAL: Outpatient Crisis Intervention Clinic
Suicidal Ideation
Suicide, Suicidal, Adolescent
Quantifying Motor Network Dynamics to Predict and Enhance Outcomes in Pediatric Dystonia
Karlee Migneault - karlee.migneault@cchmc.org
ALL
6 years to 21 years old
NA
NCT07325175
Inclusion Criteria:
* For dystonia subjects:
* Dx of dystonia (with and without DBS)
* willingness and ability to complete study protocols.
* For Typically Developing Controls:
* normal developmental milestones
* absence of any neuropsychiatric disorder
* no significant medical condition.
Exclusion Criteria:
* history of epilepsy
* presence of implanted medical devices (except DBS in dystonia subjects)
* lack of cognitive or physical ability to complete study protocol. DEVICE: DBS
Dystonia, Pediatric, Deep Brain Stimulation, Motor Development
Studying Health Outcomes After Treatment in Patients With Retinoblastoma (RIVERBOAT)
Amanda Pfeiffer - amanda.pfeiffer@cchmc.org
ALL
NCT03932786
* Unilateral or bilateral intraocular retinoblastoma
* Diagnosis between the ages of 0 - 17.99 years
* Diagnosis on or after January 1, 2008
* No exclusions based on primary or secondary treatment modalities
* Retrospective group patients must be ≥ 6 months post end of treatment at study entry
* For those already at this timepoint, they are now eligible
* For those in treatment, or otherwise not yet at this timepoint, they are eligible once at they are ≥ 6 months post end of treatment
* Prospective group patients must not have begun treatment
* Patients with diminished capacity will not be enrolled.
* Language: Patients must be able to communicate in English, French, or Spanish
* Sibling Cohort: One sibling, not affected by retinoblastoma will be enrolled, preference for the sibling closest in age to the RB patient.
* Regulatory Requirements: All patients and/or their parents or legal guardians must sign a written informed consent. All institutional, FDA, and NCI requirements for human studies must be met.
PROCEDURE: Biospecimen collection, OTHER: Vision assessment, OTHER: Questionnaire administration, OTHER: Quality of life assessment, OTHER: Laboratory Biomarker Analysis
Retinoblastoma, Cancer Survivor, Biological Sibling, Intraocular Retinoblastoma, Unilateral Retinoblastoma
Heart Institute Biobank & Registry for Adult Congenital Heart Disease and Related Disorders (HIBR-ACHD)
Olivia Croweak - 0livia.croweak@cchmc.org
ALL
16 years and over
NCT07477197
Inclusion Criteria:
• Any person ≥ 16 years-old suspected of having or diagnosed with congenital heart disease (CHD), other cardiovascular disease (CVD), pulmonary hypertension, connective tissue disease, or genetic syndrome/diagnosis.
• Additionally, a cohort (Control group A) of control subjects will be enrolled, again ≥16 years-old, self-reported non-smokers without a known history of diabetes mellitus, myocardial infarction, stroke, heart failure, or chronic kidney disease. These controls will be either:
• A family member or other person accompanying a patient to a clinical encounter; or,
• A volunteer recruited via an advertisement; or,
• Another person who volunteers to enroll in HIBR-ACHD.
• A cohort (Control group B) of comparison subjects who do not have CHD, but have a diagnosis of heart failure or pulmonary hypertension.
Exclusion Criteria:
* Unable to provide informed consent/assent personally or via a legal guardian.
* Considered unsafe to collect the biospecimen determined by either a clinical provider or an HIBR-ACHD investigator.
* Overnight hospitalization for non-obstetric reason with discharge in the prior 30 days. Adult Congenital Heart Disease, Pulmonary Hypertension, Connective Tissue Disease, Other Cardiovascular Conditions
ACHD, Adult Congenital Heart Disease
Assessing Pulmonary Changes in HSCT
Ashley Borden, MPH - ashley.borden@cchmc.org
ALL
3 years and over
PHASE1
NCT07823036
Inclusion Criteria:
* Ages 3 years and older
Exclusion Criteria:
* Pregnancy or positive pregnancy test
* Baseline oximetry at MRI visit of less than 90% on room air or less than 90% on a previously prescribed dosage of oxygen delivered by nasal cannula. In some cases of cardiorespiratory disease, if the participant is referred to this research study by their treating physician and considered stable for imaging, the cardiorespiratory criteria will be 5% of their clinical baseline. This should be documented in the research record upon referral of a participant that meets this scenario.
* Any condition in the opinion of the investigator that would make the participant unable to tolerate the MRI procedure (e.g., neurocognitive delay, behavioral issues).
* Standard MRI exclusions (e.g., metal, incompatible implants). DRUG: Hyperpolarized 129 Xenon
HSCT, Respiratory, Gas Exchange Impairment
Lorlatinib for Newly-Diagnosed High-Grade Glioma With ROS or ALK Fusion
Diarra Diop - diarra.diop@cchmc.org
ALL
1 year to 21 years old
EARLY_PHASE1
NCT06333899
Inclusion Criteria:
• Patients must be ≥ 12 months and ≤ 21 years of age at the time of study enrollment on TarGeT-SCR.
• Diagnosis: Patients with newly diagnosed high-grade glioma (HGG), including diffuse intrinsic pontine gliomas (DIPG), whose tumors harbor an ALK or ROS-1 fusion alteration are eligible. Patients must have had histologically verified high-grade glioma from diagnostic biopsy or resection. For the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, with histopathology consistent with diffuse WHO Grade 2-4. All other HGGs must be Grade 3 or 4.
• Disease Status: Patients with disseminated DIPG or HGG are eligible only if the patient is to receive chemotherapy only, i.e. no craniospinal RT is intended to be given. MRI of spine must be performed if disseminated disease is suspected clinically by the treating physicians. Patients with primary spinal tumors are eligible only if the patient is to receive either chemotherapy or focal radiation therapy, i.e., no craniospinal RT is intended to be given. Patients with leptomeningeal disease only, with no definitive identifiable primary tumor, and documented ALK or ROS-1 fusion, must be discussed with the Study Chair on a case-by-case basis.
• Performance Level: Karnofsky ≥ 50% for patients \> 16 years of age and Lansky ≥ 50 for patients ≤ 16 years of age (See Appendix I). Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
• Prior Therapy: * Patients must not have received any prior anti-cancer chemotherapy. * Prior use of corticosteroids is allowed (see below Exclusion Criteria)
• Organ Function Requirements 6.1 Adequate Bone Marrow Function Defined as: * Peripheral absolute neutrophil count (ANC) ≥ 1000/μL * Platelet count ≥ 100,000/μL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) * Hemoglobin \>8 g/dL (may receive transfusions) 6.2 Adequate Renal Function Defined as: * Serum creatinine within normal institutional limits OR Creatinine clearance or radioisotope GFR ≥ 70ml/min/1.73 m2 6.3 Adequate Liver Function Defined as: * Total bilirubin ≤ 2 × institutional upper limit of normal * AST(aspartate aminotransferase)/ALT(alanine transaminase) ≤ 2.5 × institutional upper limit of normal 6.4 Adequate Pulmonary Function Defined as: Pulse oximetry \> 94% on room air if there is clinical indication for determination (e.g. dyspnea at rest).
• 5Adequate Cardiac Function Defined as: QTc ≤ 470 msec (by Bazett formula) 6.6 Adequate Neurologic Function Defined as: Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled.
• 7 Informed Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines
Exclusion Criteria:
• Pregnant or breast-feeding women will not be entered on this study due to unknown risks of fetal and teratogenic adverse events as seen in animal/human studies. Pregnancy tests must be obtained in girls who are post-menarchal. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. Females of reproductive potential must use an effective non-hormonal method of contraception, since lorlatinib can render hormonal contraceptives ineffective, during study treatment and for at least 6 months after the final dose. Males with female partners of reproductive potential must use effective contraception during treatment with lorlatinib and for 3 months after the final dose.
• Concomitant Medications * Investigational Agents/Drugs: Patients who have previously received or are currently receiving another investigational drug are not eligible. * Anti-cancer Agents: Patients who have previously received or are currently receiving other anti-cancer agents, including chemotherapy, immunotherapy, monoclonal antibodies, biologic or targeted therapy, are not eligible
• Infection: Patients must not have any active, uncontrolled systemic bacterial, viral or fungal infection.
• Patients who have received prior solid organ transplantation are not eligible.
• Patients must not have malabsorption syndrome or other condition affecting oral absorption.
• Patients must not be receiving any treatment with a strong cytochrome P450 3A4 (CYP3A4) inhibitor or inducer. Discontinue strong CYP3A inducers for 3 plasma half-lives of the strong CYP3A inducer prior to treatment with loraltinib. Moderate inducers of CYP3A4 should be avoided
• Avoid concomitant use of lorlatinib with certain CYP3A substrates, for which minimal concentration changes may lead to serious therapeutic failures. If concomitant use is unavoidable, increase the CYP3A substrate dosage in accordance with approved product labeling.
• P-glycoprotein (P-gp) substrates: Lorlatinib is considered a moderate P-gp inducer. Co-administration of lorlatinib with P-gp substrates including but not limited to digoxin should be avoided as the concentration of these drugs may be reduced by lorlatinib.
• Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
• Patients with a known personal history of acute or chronic severe psychiatric disorders or current history of suicidal ideation and history of suicide attempt.
DRUG: Lorlatinib, DRUG: Lorlatinib with chemotherapy1, DRUG: Lorlatinib with chemotherapy 2, DRUG: Lorlatinib post Radiation
High Grade Glioma, Diffuse Intrinsic Pontine Glioma, Anaplastic Astrocytoma, Infant Type Hemispheric Glioma, Glioblastoma, Glioblastoma Multiforme, WHO Grade III Glioma, WHO Grade IV Glioma, Diffuse Midline Glioma, H3K27-altered
ALK fusion, ROS fusion, High Grade Glioma, Diffuse Intrinsic Pontine Glioma
BEATRIX: A Study to Learn About a Group B Streptococcus Vaccine in Healthy Pregnant Women and Their Babies
Natalie Brinkmann - natalie.brinkmann@cchmc.org
ALL
1 day to 49 years old
PHASE3
NCT07160244
Key Inclusion criteria- Maternal:
* Healthy pregnant women ≤49 years of age who are between 24 0/7 and 36 0/7 weeks of gestation on the day of planned vaccination, with an uncomplicated, singleton pregnancy, and who have no known increased risk of complications.
* Had a fetal anomaly ultrasound examination with no significant fetal abnormalities observed.
* Documented negative human immunodeficiency virus (HIV) antibody test, syphilis test, and hepatitis B virus (HBV) surface antigen test during this pregnancy and prior to randomization.
* Capable of giving personal signed informed consent.
* Willing to give informed consent for her infant to participate in the study.
Key Exclusion criteria- Maternal:
* Prepregnancy body mass index (BMI) of \>40 kg/m2.
* Current pregnancy complications or abnormalities that may increase the risk associated with the participation in and completion of the study.
* Prior pregnancy complications or abnormalities that, based on the investigator's judgment, may increase the risk associated with the participation in and completion of the study.
* History of microbiologically proven invasive disease caused by GBS in the current pregnancy.
* A known or suspected infection during the current pregnancy that may increase the risk of complications in pregnancy (eg, active tuberculosis, syphilis, primary genital herpes simplex, malaria).
Key Inclusion criteria- Infant Participants
\- Evidence of a signed and dated ICD signed by the parent(s)/legally authorized representative or legal guardian
Key Exclusion Criteria - Infant Participants:
\- Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly involved in the conduct of the study.
Key Exclusion Criteria - Infant immunogenicity subset Participants:
\- Children with a known or suspected contraindication to any vaccine administered in the infant vaccine immunogenicity subset.
Refer to the study contact for further eligibility details
BIOLOGICAL: Multivalent Group B streptococcus vaccine, BIOLOGICAL: Placebo, BIOLOGICAL: Infanrix hexa, BIOLOGICAL: Prevenar 20, BIOLOGICAL: Pediarix, BIOLOGICAL: Prevnar 20, BIOLOGICAL: Infanrix
Healthy
group B streptococcus, maternal immunization, vaccine