NICHD Neonatal Research Network Background and Overview
In 1986, the
Eunice Kennedy Shriver National Institute of Child Health and Human Development
part of the National Institutes of Health, initiated the Neonatal Research
Network to conduct multi-center clinical trials and observational studies in
neonatal medicine. The network was created because many of the treatment and
management strategies in 1986 had become standards without being properly
evaluated. In addition, multiple clinical centers were necessary to provide a
large enough population from which appropriate (with adequate statistical power
to detect clinically important differences) samples could be drawn. At the same
time, NICHD also established a companion
Maternal Fetal Medicine Unit
(MFMU) Network to do similar research in obstetrics and maternal-fetal medicine.
Neonatal Research Network Studies
Among the areas addressed by the Neonatal Research Network are studies on the prevention of sepsis, intraventricular hemorrhage,
pulmonary hypertension, surfactant administration, and outcome and resource requirements for very low birth weight (VLBW) infants were
initiated. In addition, the Network has established a generic database of low birthweight and extremely premature infants. Clinical trials have
also been conducted on the prevention or treatment of chronic lung disease (CLD), intraventricular hemorrhage, retinopathy of prematurity,
and persistent pulmonary hypertension. Studies of VLBW maturity and postnatal growth, the sequelae of the fetal drug exposure, and a
standardized follow-up program were also initiated. Other areas addressed include parenteral glutamine, indomethacin, erythropoietin,
inhaled nitric oxide, postnatal steroids, ventilation management strategies, necrotizing enterocolitis, whole body cooling for asphyxia,
benchmarking practices for bronchopulmonary dysplasia, phototherapy for extremely low birth weight infants, continuous positive airway
pressure in the delivery room, candidal infections, neonatal infections, pneumococcal vaccine in very low birth weight infants, transfusion,
and follow up of high risk infants.
The clinical centers participating in the cooperative
agreement with NICHD represent academic institutions with experience in
multi-center clinical research. They have agreed to abide by the study
protocols and have comparable staff, facilities, and equipment.
The Principal Investigator assumes responsibility for all aspects
of the center's participation in the Network and participates (with the NICHD
and Data Coordinating Center) as a member of the Steering Committee.
The Research Coordinator oversees the conduct of the Network
clinical trials. Under the supervision of the PI, the Coordinator is responsible
for the conduct of Network protocols, including adherence to protocols,
collection of data, supervision of data transmission, data quality, and staff
Data Coordinating Center
The primary objective of the Data Coordinating Center,
RTI International, is to provide
data management and biostatistical support and consultation in the areas of design, execution, and
analysis for the Network studies. RTI also assists in development of the study
materials, including the protocols, study manuals and forms.
The NICHD Neonatal Research Network Program Scientist provides substantial
scientific support as a participant in the scientific efforts of the Network,
as well as in review and oversight of the efforts of the Network.
The Neonatal Research Network Steering Committee has primary responsibility for
the development and conduct of protocols and the preparation of publications.
The Steering Committee membership is limited to the Principal Investigator from
each Clinical Center, the Principal Investigator from the Data Coordinating Center,
and the NICHD Program Scientist. An outside Steering Committee Chairman (who is
not participating as a principal investigator and will not ordinarily vote) is
appointed by the NICHD.