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Search Results Within Category "Pregnancy/Infants"

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.

9 Study Matches

Generic Database of Very Low Birth Weight Infants (GDB)

The Generic Database (GDB) is a registry of very low birth weight infants born alive in NICHD Neonatal Research Network (NRN) centers. The GDB collects observational baseline data on both mothers and infants, and the therapies used and outcomes of the infants. The information collected is not specific to a disease or treatment (i.e., it is "generic"). Data are analyzed to find associations and trends between baseline information, treatments, and infant outcome, and to develop future NRN trials.

Brenda Poindexter - brenda.poindexter@cchmc.org

ALL
Up to 0 month(s) old
This study is NOT accepting healthy volunteers
NCT00063063
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Inclusion Criteria:
* Infants inborn at NICHD NRN centers that are: * 401-1000 grams birth weight, and/or * 20 0/7 to 28 6/7 weeks (\<29 weeks) gestational age * Infants enrolled in one or more additional NICHD NRN interventional trials or time-limited observational studies. For infants that do not meet the inclusion criteria above, inclusion and exclusion criteria for the Generic Database are determined by the criteria for the additional trial(s). In these cases, infants that are larger than 1,000 grams and/or older than 29 weeks may be included in the GDB.
Exclusion Criteria:
* Infants \>1,000 grams birth weight and/or \>29 weeks gestational age Note: These inclusion criteria were changed as of 1/1/2008. Prior to this date, all infants with birth weights between 401 and 1500 grams who are admitted to NRN NICUs within 14 days of birth were included in the database.
OTHER: No Intervention
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity
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Multisite Inventory of Neonatal-Perinatal Interventions (MINI) Minimum Dataset

The goal of the Tiny Baby Collaborative Multicenter Inventory of Neonatal-Perinatal Interventions (MINI) minimum dataset is to serve as a registry detailing the outcomes and practices for all deliveries and infants admitted to intensive care at 22-23 weeks' gestation at participating hospitals.

Faris Algharaibeh - faris.algharaibeh@cchmc.org

ALL
0 years to 1 year old
NCT05685745
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Inclusion Criteria:
* All local births with gestational ages of 22 weeks 0 days - 23 weeks 6 days, regardless of pregnancy outcome or neonatal intensive care (NICU) admission; AND * All outborn NICU admissions with gestational age at birth of 22 weeks 0 days - 23 weeks 6 days * Optional: Centers who desire to include data for NICU admissions of infants born \<22 weeks' gestation may also submit these data.
Infant, Extremely Premature, Obstetric Labor, Premature, Premature Birth, Intensive Care, Neonatal, Intensive Care Units, Neonatal
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FST Analysis Supporting Timely Therapy and Risk Assessment Via Clinical Decision Support for Kids (FAST TRACK)

The goal of this study is to learn whether adding a clinical decision support tool to the electronic medical record helps clinicians use the furosemide stress test in critically ill children at high risk for severe acute kidney injury (AKI). The main question it aims to answer is: Does implementing the decision support tool reduce fluid overload and help predict which children will receive dialysis? Researchers will identify children admitted to the pediatric intensive care unit who are at high risk for AKI using risk stratification and biomarker testing, then compare outcomes in the two years after the tool is introduced with the two years before.

Natalja L Stanski, MD, MS - natalja.stanski@cchmc.org

ALL
This study is NOT accepting healthy volunteers
NCT07718464
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Inclusion Criteria:
* Admitted to the pediatric intensive care unit (PICU) * Renal Angina Index (RAI) greater than or equal to 8 (RAI+) * Urine NGAL greater than or equal to 150 ng/mL (NGAL+)
Exclusion Criteria:
* Receipt of renal replacement therapy prior to PICU admission
OTHER: Furosemide Stress Test Clinical Decision Support Tool
Acute Kidney Injury, Renal Replacement Therapy, Pediatric Intensive Care Unit
NGAL, Renal Angina Index, Furosemide Stress Test
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Follow-up Visit of High Risk Infants (FU)

The NICHD Neonatal Research Network's Follow-Up study is a multi-center cohort in which surviving extremely low birth-weight infants born in participating network centers receive neurodevelopmental, neurosensory and functional assessments at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). Data regarding pregnancy and neonatal outcome are collected prospectively. The goal is to identify potential maternal and neonatal risk factors that may affect infant neurodevelopment.

Traci Beiersdorfer - traci.beiersdorfer@cchmc.org

ALL
18 months to 26 months old
This study is NOT accepting healthy volunteers
NCT00009633
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* Infants inborn at NRN centers * \<27 weeks gestational age * Infants enrolled in one or more additional NICHD NRN Follow-up studies. For infants that do not meet the inclusion criteria above, inclusion and exclusion criteria are determined by the criteria for the additional trial(s). In these cases, infants that are larger than 1,000 grams and/or older than 27 weeks may be included in the FU Study. Note: These inclusion criteria were changed as of 1/1/2008. Prior to this date, infants with birth weights between 401 and 1500 grams who were admitted to NRN NICUs within 14 days of birth were included in the database.
OTHER: No Intervention
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature
NICHD Neonatal Research Network, Extremely Low Birth Weight (ELBW), Prematurity, Neurodevelopmental Outcome, Follow up studies
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I-InTERACT Preterm Parenting (I2P-RCT)

Many children born very preterm experience behavior problems, and existing resources for parenting these children are lacking. A pilot trial established the effectiveness of a preterm parenting intervention, I-Interact Preterm (I2P). This study proposes a three-arm randomized controlled trial (RCT) comparing the established seven-session I2P program, a microlearning delivery mode (I2P-Micro), and an internet resource comparison group (IRC). Outcomes will be assessed at pretreatment, post-treatment (12 weeks later), and at an extended follow-up six months post-randomization. These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in significant improvements relative to the IRC condition, with greater utilization expected in the I2P-Micro group.

Zyah Flagg - zyah.flagg@cchmc.org

ALL
3 years to 8 years old
NA
This study is also accepting healthy volunteers
NCT06767293
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Inclusion Criteria:
* Born at \< 32 weeks gestational age. * Total T score of \> 55 on the Child Behavior Checklist Total or Externalizing Behavior Scales OR Total T score of \> 55 on the Eyberg Child Behavior Inventory total problem- or total intensity-scale. * English is the primary spoken language in the home.
Exclusion Criteria:
* Is not 18 years or older. * Participant will be excluded from the study if the child does not reside with the caregiver at least half-time; the caregiving situation is not stable (i.e., there must be no scheduled custody hearings). * English is not the primary language spoken in the home. * Caregivers with a psychiatric hospitalization in the past year.
BEHAVIORAL: I-InTERACT Parenting Intervention (I2P) and coaching sessions, BEHAVIORAL: I-InTERACT Parenting Microlearning Intervention (I2P Micro) and coaching sessions, OTHER: Internet Resources
Child Behavior Problem, Preterm, Parent-Child Relations, Parenting
telehealth, online learning, microlearning
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Target Trial Emulation for Pharmacologic Treatment of Neonatal Opioid Withdrawal Syndrome (TreaT NOW)

The goal of this observational study is to learn how two medicines used in routine care-buprenorphine and morphine-affect recovery in newborns (≥36 weeks' gestation) with Neonatal Opioid Withdrawal Syndrome (NOWS). The main questions it aims to answer are: 1. Do infants treated with buprenorphine become medically ready for discharge sooner than those treated with morphine? 2. Does one treatment lead to better overall clinical outcomes than the other? Researchers will compare infants who received buprenorphine with infants who received morphine to see whether one treatment helps babies recover more quickly. Participants will not be asked to do anything. Instead, the study team will collect information already documented in the infant's and mother's medical records securely without any contact or changes to clinical care. No new medicines, procedures, or visits are involved. This study only reviews existing clinical data to better understand which commonly used treatment may support faster recovery for newborns with NOWS.

Traci Beiersdorfer - Traci.Beiersdorfer@cchmc.org

ALL
Not specified
This study is NOT accepting healthy volunteers
NCT07278375
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Inclusion Criteria:

• Infant is ≥ 36 weeks' gestational age
• Infant had antenatal opioid exposure identified by at least one of the following:
• History of maternal opioid use during the second and/or third trimester of pregnancy as noted in the mother's or infant's medical record;
• Positive maternal toxicology screen for opioids during the second or third trimester of pregnancy; and/or
• Positive infant toxicology screen for opioids during the initial hospital stay.
• The infant is being assessed and managed for NOWS at an eligible study site.
• The infant is at risk for pharmacologic treatment for NOWS defined by either of the following: * At least 1 score ≥ 8 if assessed and managed with the Finnegan Neonatal Abstinence Scoring Tool (FNAST) or modification thereof * At least 1 "yes" if assessed and managed with the Eat, Sleep, Console (ESC) care approach
• Infant met all inclusion criteria on or after March 25, 2024.
Exclusion Criteria:

• Infant has major congenital anomalies.
• Infant has neonatal encephalopathy (inclusive of hypoxic ischemic encephalopathy), a metabolic disorder, stroke, intracranial hemorrhage, or meningitis diagnosed prior to the initiation of pharmacologic treatment.
• Infant is receiving respiratory support (any positive pressure or oxygen therapy) at 48 hours of age.
• Infant has undergone major surgical intervention prior to or at 48 hours of age.
• Infant has postnatal opioid exposure prior to the initiation of pharmacologic treatment for NOWS.
• Infant was outborn and pharmacologic treatment was initiated at the transferring hospital.
Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, NOWS
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Neonatal Platelet Transfusion Threshold Trial (NeoPlaTT)

The objective of the NeoPlaTT trial is to test whether, among extremely preterm infants born at 23 0/7 to 26 6/7 weeks' gestation, a lower platelet transfusion threshold, compared to a higher threshold, improves survival without major or severe bleeding up to 40 0/7 weeks' postmenstrual age (PMA).

Traci Beiersdorfer - traci.beiersdorfer@cchmc.org

ALL
1 hour to 48 hours old
NA
This study is also accepting healthy volunteers
NCT06676904
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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
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HeartGPS: A Study Exploring the Effects of a Psychological Intervention for Parents and Their Babies After Prenatal Cardiac Diagnosis (HeartGPS)

Babies with single ventricle congenital heart disease (SVCHD) are often diagnosed during pregnancy. While prenatal diagnosis has important clinical benefits, it is often stressful and overwhelming for parents, and many express a need for psychological support. HeartGPS is a psychological intervention for parents who receive their baby's diagnosis of SVCHD during pregnancy. It includes 8 sessions with a psychologist, coupled with tailored educational resources, and a personalized care plan. The intervention focuses on fostering parent psychological adjustment and wellbeing, and supporting parents to bond with their baby in ways that feel right for them. Through this study, the investigators will learn if HeartGPS is useful and effective for parents and their babies when it is offered in addition to usual fetal cardiac care. The investigators will examine the effects of the HeartGPS intervention on parental anxiety, depression, and traumatic stress; fetal and infant brain development; parent-infant bonding; and infant neurobehavioral and neurodevelopmental outcomes. The investigators will also explore mechanisms associated with stress biology during pregnancy, infant brain development and neurodevelopmental outcomes, and parent and infant intervention effects.

- heartgps@cchmc.org

ALL
18 years and over
NA
This study is NOT accepting healthy volunteers
NCT06175104
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Inclusion Criteria
• Pregnant person carrying a fetus diagnosed with single ventricle congenital heart disease (CHD).
• Single ventricle CHD diagnosis between 16 and 30 weeks gestation.
• Singleton pregnancy.
• Pregnant person is planning to continue with the pregnancy.
• Pregnant person is able to participate and complete study assessments in English. Exclusion Criteria
• Fetus with comorbid condition with a predictable adverse impact on neurodevelopment (e.g., DiGeorge Syndrome).
• Fetal or maternal medical condition determined by treating physician to be contraindicative to study participation.
• Parent with an untreated major psychiatric condition, substance use disorder, or other circumstances that would interfere with study engagement or safe participation in the trial.
• Parent with a moderate to severe intellectual disability.
• Parent age \<18 years.
• Surrogate for pregnancy. Prenatal administration of oral or intravenous corticosteroids for fetal lung maturation will be recorded but are not a reason for exclusion.
BEHAVIORAL: HeartGPS
Heart Defects, Congenital, Anxiety in Pregnancy, Depression, Postpartum, Trauma, Psychological, Neurodevelopmental Disorders
Congenital Heart Disease, Prenatal, Mental Health, Neurodevelopment, Neurobehavior, Fetal Cardiology, Psychological Intervention, Mother-Infant Attachment, Mother-Infant Bonding, Medical Traumatic Stress, Neuroimaging, Brain Development, Fetal Neuroimaging, Perinatal Mental Health, Medical Psychology
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A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects Aged 0 to <18 (ROSSELLA)

This is a Phase 3, open-label, multicenter study to evaluate the safety, efficacy, PK, PD, and immunogenicity of cipaglucosidase alfa/miglustat treatment in ERT-experienced and ERT-naïve pediatric subjects with IOPD.

Laurie Bailey - laurie.bailey@cchmc.org

ALL
Up to 17 years old
PHASE3
This study is NOT accepting healthy volunteers
NCT04808505
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Inclusion Criteria:
Cohort 1:
• Male or female subjects who are aged 6 months to \< 18 years on Day 1
• Subject must have documentation of IOPD genotype
• Subject must have had hypertrophic cardiomyopathy at the time of diagnosis
• Subject must have received ERT for at least 6 months immediately before enrollment. For subjects whose ERT dosage has been modified, the subject must have been on the modified dosage and regimen for at least 3 months before enrollment
• Subjects aged ≥ 12 to \< 18 years must perform one valid 6-minute walk test (6MWT) (≥ 75 meters) at screening; Subjects aged ≥ 5 to \< 12 years must perform one valid 6MWT (≥ 40 meters) at screening; Subjects aged 18 months to \< 5 years must be ambulatory and assessed to be likely to be able to perform 6MWT (≥ 40 meters) when they turn 5 years old
• Subjects must have experienced a clinical decline on their current rhGAA dose and frequency Cohort 2:
• Male or female subjects who are aged 0 to \<6 months at Day 1
• Subject must have documentation of IOPD genotype
• Subject must have had hypertrophic cardiomyopathy at the time of diagnosis
• Subject is ERT-naïve Long-term Extension (Cohort 1 or Cohort 2): 1\. Subject must have, in the opinion of the investigator, benefited from therapy with cipaglucosidase alfa/miglustat during the 104-week primary treatment period with no significant safety concerns.
Exclusion Criteria:
Cohort 1 and Cohort 2, unless specified
• Subject requires invasive ventilation (eg, tracheostomy)
• Subject is CRIM negative and has not received prophylactic immunomodulation (Cohort 1); Subject is CRIM negative and will not be receiving prophylactic immunomodulation (Cohort 2)
• Subject has a history of life-threatening IARs/hypersensitivity (eg, anaphylaxis and severe cutaneous reactions) to ERT (eg, alglucosidase alfa, cipaglucosidase alfa, miglustat) or other iminosugars, or to any of the excipients, where rechallenge was unsuccessful
• Subject has prior history of illness or condition known to affect motor function
• Female subject is pregnant (or intends to get pregnant) or breastfeeding at screening (Cohort 1)
BIOLOGICAL: Cipaglucosidase alfa, DRUG: Miglustat
Glycogen Storage Disease Type II Infantile Onset
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