Co-Principal Investigator: Joel I. Verter, Ph.D.

n 1985, the National Institute of Child Health and Human Development (NICHD) of the National Institutes of Health (NIH) established the Neonatal Intensive Care Units (NICU) Network. The NICU Network conducted clinical trials and epidemiologic studies in neonatal medicine. Many of the current treatment and management strategies in perinatal medicine have become standards of care without proper evaluation through well designed research protocols. For many of the regimens needing evaluation, the sample size required for adequate power to detect clinically important differences exceeds the patient population resources of individual clinical centers. Thus, the Neonatal Intensive Care Units (NICU) Network focused on those questions in perinatal medicine which require a multicenter effort to obtain adequate numbers of eligible patients, and which have the potential for affecting major risk factors for perinatal morbidity and mortality. The Biostatistics Center was the Biostatistical Coordinating Center for the NICU Network December 1986 until September 1998.

he NICU Network consisted of 14 NICU clinics and implemented, executed or analyzed multiple projects simultaneously (registries, randomized clinical trials, and cohort studies). The purpose of these studies was to evaluate various aspects or interventions related to the management of infants in neonatal intensive care units.

he randomized clinical trials included: 1) Steroid Trial: an investigation of the use of dexamethasone therapy in reducing the risk of chronic lung disease (371 mothers at 12 centers), 2) Phenobarbital Trial: a trial testing the ability of prelabor use of phenobarbital in reducing the early risk of neonatal mortality and hemorrhage (610 mothers and 668 infants at 9 centers), 3) Nitric Oxide Trial: a trial evaluating the use of nitric oxide to reduce the risk of death or the need for ECMO (235 infants at 18 US and Canadian clinical centers), 4) Vitamin A Trial: a randomized trial to evaluate the use of vitamin A to reduce the risk of death or chronic lung disease (800 infants at 14 clinical centers). Other studies in recruitment include: assessment of physical and neurodevelopmental status at 18 months of age for babies born 401-1000 grams; a non-randomized prospective study of the impact of the use of antenatal magnesium sulfate in mothers delivering babies 401-1000 grams. In addition, the Very Low Birthweight Registry (VLBW) and the Extremely Low Birthweight Registry (ELBW), are generic data bases of information and outcome measures on over 20,000 infants born weighing between 401 and 1500 gms which are being managed by the Center.

hree recently (1995-1996) completed studies reported the following results: the Dexamethasone Trial reported no difference in the time to extubation between a group of neonates given steroids on day 14 of age versus the group receiving steroids on day 28, if still needed; the Phenobarbital Trial was stopped early after a finding of no difference in the risk of early death or intraventricular hemorrhage; the Nitric Oxide Trial was terminated early after a significant reduction in the risk of death or the need for ECMO was found. NICHD Cooperative Agreement 5-U01-HD19897, 1986-1998.