Active and Completed Studies
ACTIVE OBSERVATIONAL STUDIES
Follow-up of infants born less than or equal to 26 completed weeks gestational age at 22-26 months corrected age (Infants born prior to July 1, 2012 were seen at 18-22 months corrected age). A sub-study will compare Bayley scores from a cohort of Term Reference infants.Protocol Manual Forms
The Generic Data Base Study (GDB): Survey of Morbidity and Mortality in Very Low Birth Weight (VLBW) Infants.Manual Forms
Follow-up of infants enrolled in the Hydrocortisone for BPD Trial at 5-6 years corrected age to assess functional developmental and respiratory outcomes at early school age.
Follow-up of infants enrolled in the TOP Trial at 5-6 years corrected age to assess neurological and functional outcomes at early school age based on neonatal transfusion threshold..
ACTIVE RANDOMIZED CLINICAL TRIALS
The Budesonide in Babies (BiB).
Trial to Improve Red Cell Mass and Neuroprotection in Preterm Infants.
A Randomized Controlled Trial of the Effect Of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22 - 26 Months of Age in Intubated Infants < 30 Weeks Gestation Age.
Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in ELBW infants.
Milrinone in Congenital Diaphragmatic Hernia.
Moderately Preterm Infants With Caffeine at Home for Apnea (MoCHA) Trial (MoCHA)
A Multi-center Randomized Trial of Laparotomy vs. Drainage as the Initial Surgical Therapy for ELBW Infants with Necrotizing Enterocolitis (NEC) or Isolated Intestinal Perforation (IP): Outcomes at 18-22 months Adjusted Age.
Management of the PDA Trial (PDA)
A Randomized Trial of Targeted Temperature Management With Whole Body Hypothermia For Moderate And Severe Hypoxic-Ischemic Encephalopathy In Premature Infants 33-35 Weeks Gestational Age.
Does a Liberal Red Blood Cell Transfusion Strategy Improve Neurologically-Intact Survival of Extremely-Low-Birth-Weight Infants as Compared to a Restrictive Strategy?
COMPLETED OBSERVATIONAL STUDIES
Do Antenatal Steroids Affect Maturation of the Amplitude Integrated Electroencephalogram in Late Preterm Infants? A Secondary Study by the NRN for the MFMU ALPS Trial.
Early-Onset Sepsis an NICHD/CDC Surveillance Study.
Development of Standards for the New Ballard Maturation Score.
Early Diagnosis of Nosocomial Candidiasis Study.
Early Blood Pressure Management in Extremely Preterm Infants Feasibility Pilot Study.
Growth Observational Study.
Pilot Randomized Clinical Trial of Inhaled PGE1 in Neonates with Sub-optimal Response to Inhaled Nitric Oxide.
Prediction of Jaundice in Term Infants.
In Utero Magnesium Sulfate Exposure: Effects on Extremely Low Birth Weight (ELBW) Infants.
Time Limited Observational Study of the Moderately Preterm Infant (29 0/7 - 33 6/7 wks).
Surgical Treatment of Necrotizing Enterocolitis or Isolated Intestinal Perforation.
Neurodiagnostic Evaluations that Assist in the Prediction of Adverse Outcomes Following Acute Perinatal Asphyxia.
Physiologic Definition of Bronchopulmonary Dysplasia.
Observational Study of the Immunogenicity of Heptavalent Pneumococcal Conjugate Vaccine in Very-Low-Birth-Weight Infants.
PPHN Observational Study.
Function Monitoring and Brain Injury In Preterm Infants: Correlation With Neuroimaging Abnormalities and Neurodevelopmental Impairment- A Pilot Study.
Hydrocortisone Treatment of Hypotension in Term and Late Preterm Infants: an Observational Study.
COMPLETED RANDOMIZED CLINICAL TRIALS
A Randomized Controlled Trial of Benchmarking to Reduce Bronchopulmonary Dysplasia.
Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants Pilot Study.
Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (ELBW) Infants.
Randomized Clinical Trial of Dexamethasone Therapy in Very Low Birth Weight (VLBW) Infants at Risk for Chronic Lung Disease (CLD).
Early Inhaled Nitric Oxide Study.
The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Preterm Infants 401-1250 Grams: Two Multi-Center, Randomized, Double-Masked, Placebo-Controlled Studies.
Randomized Controlled Trial of Parenteral Glutamine Supplementation for Extremely Low Birth Weight (ELBW) Infants.
Hydrocortisone Treatment of Cardiovascular Insufficiency in Term and Late Preterm Infants: A Randomized Controlled Trial.
Randomized Controlled Trial of Induced Hypothermia for Hypoxic Ischemic Encephalopathy in Term Infants.
Incubator Weaning of Moderately Preterm infants: A Randomized Controlled Trial.
Inositol to Reduce Retinopathy of Prematurity.
Multi-dose Pharmacokinetics and Dose Ranging of Inositol in Premature Infants (INS-2).
Single-Dose Intravenous Inositol Pharmacokinetics in Preterm Infants.
Randomized Clinical Trial of Intravenous Immune Globulin to Prevent Neonatal Infection in Very Low Birth Weight (VLBW) Infants.
Evaluation of Systemic Hypothermia Initiated After 6 Hours of Age in Infants > 36 Weeks Gestation with Hypoxic-Ischemic Encephalopathy: A Bayesian Evaluation.
Randomized Inhaled Nitric Oxide Study (NINOS).
Optimizing Hypothermia as Neuroprotection at < 6 Hours of Age for Neonatal Hypoxic Ischemic Encephalopathy.
A Randomized Trial of Aggressive or Conservative Phototherapy For Extremely Low Birth Weight (ELBW) Infants.
Inhaled Nitric Oxide for Preterm Infants with Severe Respiratory Failure.
Randomized Trial of Minimal Ventilator Support and Early Corticosteroid Therapy to Increase Survival Without Chronic Lung Disease in Extremely Low Birth Weight (ELBW) Infants.
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity.
The Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight(ELBW) Infants.
Randomized Clinical Trial of the Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome.
Early Surfactant Followed by Nasal CPAP to Reduce the Use of Mechanical Ventilation Without Additional Morbidity in Infants 1250-2000 Grams with RDS.
Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP).
Randomized Trial of Vitamin A Supplementation for Extremely Low Birth Weight (ELBW) Infants.
Single-Dose Vitamin E for Prevention of Mortality and Morbidity in Extremely Preterm Infants: Pilot Study.