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Active and Completed Studies
ACTIVE OBSERVATIONAL STUDIES
ALPS aEEG
(2012 - ongoing)
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.
 
EOS II
(2015 - ongoing)
Early-Onset Sepsis an NICHD/CDC Surveillance Study.
 
Follow-up
(1993 - ongoing)
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).
Protocol  Manual  Forms
 
Generic Database
(1987 - ongoing)
The Generic Data Base Study (GDB): Survey of Morbidity and Mortality in Very Low Birth Weight (VLBW) Infants.
Manual  Forms
 
ACTIVE RANDOMIZED CLINICAL TRIALS
Hydrocortisone for BPD
(2011 - ongoing)
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.
 
Hydrocortisone for CI
(2014 - ongoing)
Hydrocortisone Treatment of Cardiovascular Insufficiency in Term and Late Preterm Infants: A Randomized Controlled Trial.
 
Incubator Weaning
(2014 - ongoing)
Incubator Weaning of Moderately Preterm infants: A Randomized Controlled Trial.
 
A Phase 3, Randomized, Double-Masked, Placebo-Controlled Study of the Efficacy and Safety of myo-Inositol 5% Injection to Increase Survival without Severe Retinopathy of Prematurity (Reduce-ROP) in Extremely Premature Infants.
 
Late Hypothermia
(2008 - ongoing)
Evaluation of Systemic Hypothermia Initiated After 6 Hours of Age in Infants > 36 Weeks Gestation with Hypoxic-Ischemic Encephalopathy: A Bayesian Evaluation.
 
Milk Trial
(2012 - ongoing)
Neurodevelopmental Effects of Donor Human Milk vs. Preterm Formula in ELBW infants.
 
NEST
(2010 - ongoing)
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.
 
Optimizing Cooling
(2010 - ongoing)
Optimizing Hypothermia as Neuroprotection at < 6 Hours of Age for Neonatal Hypoxic Ischemic Encephalopathy.
 
Preemie Hypothermia
(2015 - ongoing)
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.
 
TOP Trial
(2012 - ongoing)
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
Ballard
(1994 - 1996)
Development of Standards for the New Ballard Maturation Score.
 
Candida
(2004 - 07/2007)
Early Diagnosis of Nosocomial Candidiasis Study.
 
Early BP
(07/2009 - 07/2010)
Early Blood Pressure Management in Extremely Preterm Infants Feasibility Pilot Study.
 
EOS
(02/2006 - 12/2009)
Early-Onset Sepsis.
 
Growth
(1994 - 1995)
Growth Observational Study.
 
IPGE1
(2011 - 2012)
Pilot Randomized Clinical Trial of Inhaled PGE1 in Neonates with Sub-optimal Response to Inhaled Nitric Oxide.
 
Jaundice Screen
(1991 - 1992)
Prediction of Jaundice in Term Infants.
 
Mag Sulfate
(1996 - 1998)
In Utero Magnesium Sulfate Exposure: Effects on Extremely Low Birth Weight (ELBW) Infants.
 
Moderate Preterm
(2012 - 2013)
Time Limited Observational Study of the Moderately Preterm Infant (29 0/7 - 33 6/7 wks).
 
NEC
(2001 - 2002)
Surgical Treatment of Necrotizing Enterocolitis or Isolated Intestinal Perforation.
 
New aEEG
(2005 - 2006)
Neurodiagnostic Evaluations that Assist in the Prediction of Adverse Outcomes Following Acute Perinatal Asphyxia.
 
Physiologic Definition of Bronchopulmonary Dysplasia.
 
PCV-7
(2004 - 11/2006)
Observational Study of the Immunogenicity of Heptavalent Pneumococcal Conjugate Vaccine in Very-Low-Birth-Weight Infants.
 
PPHN
(1993 - 1994)
PPHN Observational Study.
 
Preemie aEEG
(07/2009 - 06/2010)
Function Monitoring and Brain Injury In Preterm Infants: Correlation With Neuroimaging Abnormalities and Neurodevelopmental Impairment- A Pilot Study.
 
Term Hypotension
(04/2009-12/2009)
Hydrocortisone Treatment of Hypotension in Term and Late Preterm Infants: an Observational Study.
 
COMPLETED RANDOMIZED CLINICAL TRIALS
Benchmarking
(2000 - 05/2004)
A Randomized Controlled Trial of Benchmarking to Reduce Bronchopulmonary Dysplasia.
 
Cord Clamping
(2000 - 2001)
Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants Pilot Study.
 
Delivery Room CPAP
(2002 - 2003)
Delivery Room Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) in Extremely Low Birth Weight (ELBW) Infants.
 
Dexamethasone
(1992 - 1994)
Randomized Clinical Trial of Dexamethasone Therapy in Very Low Birth Weight (VLBW) Infants at Risk for Chronic Lung Disease (CLD).
 
Early INO
(1998 - 2001)
Early Inhaled Nitric Oxide Study.
 
EPO I and II
(1997 - 1998)
The Effects of Erythropoietin (EPO) on the Transfusion Requirements of Preterm Infants 401-1250 Grams: Two Multi-Center, Randomized, Double-Masked, Placebo-Controlled Studies.
 
Glutamine
(1999 - 2004)
Randomized Controlled Trial of Parenteral Glutamine Supplementation for Extremely Low Birth Weight (ELBW) Infants.
 
Hypothermia
(1999 - 05/2003)
Randomized Controlled Trial of Induced Hypothermia for Hypoxic Ischemic Encephalopathy in Term Infants.
 
Inositol
(01/2010 - 11/5/2010)
Multi Dose Inositol Pharmacokinetics and Outcomes in Premature Infants (INS-2)-Pilot Study.
 
Inositol Single Dose Pilot
(02/2006 - 08/2007) (Revised 05/2006)
Single Dose Intravenous Inositol Pharmacokinetics in Preterm Infants.
 
IVIG
(1987 - 1991)
Randomized Clinical Trial of Intravenous Immune Globulin to Prevent Neonatal Infection in Very Low Birth Weight (VLBW) Infants.
 
NINOS
(1995 - 1996)
Randomized Inhaled Nitric Oxide Study (NINOS).
 
Phototherapy
(2002 - 04/2005)
A Randomized Trial of Aggressive or Conservative Phototherapy For Extremely Low Birth Weight (ELBW) Infants.
 
Preemie INO
(2001 - 09/2003)
Inhaled Nitric Oxide for Preterm Infants with Severe Respiratory Failure.
 
SAVE
(02/1998 - 09/1998)
Randomized Trial of Minimal Ventilator Support and Early Corticosteroid Therapy to Increase Survival Without Chronic Lung Disease in Extremely Low Birth Weight (ELBW) Infants.
 
STOP ROP
(1993 - 1999)
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity.
 
SUPPORT
(2005 - 02/2009)
The Surfactant Positive Airway Pressure and Pulse Oximetry Trial in Extremely Low Birth Weight(ELBW) Infants.
 
Surfactant
(1991 - 1992)
Randomized Clinical Trial of the Efficacy and Safety of Exosurf Neonatal and Survanta for the Treatment of Respiratory Distress Syndrome.
 
Surfactant/CPAP
(2000 - 2001)
Early Surfactant Followed by Nasal CPAP to Reduce the Use of Mechanical Ventilation Without Additional Morbidity in Infants 1250-2000 Grams with RDS.
 
TIPP
(1993 - 1996)
Trial of Indomethacin Prophylaxis in Preterm Infants (TIPP).
 
Vitamin A
(1996 -1997)
Randomized Trial of Vitamin A Supplementation for Extremely Low Birth Weight (ELBW) Infants.
 
Vitamin E
(2010 - 2011)
Single-Dose Vitamin E for Prevention of Mortality and Morbidity in Extremely Preterm Infants: Pilot Study.