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 trials of
therapies for sepsis, intraventricular hemorrhage, chronic lung disease, and
pulmonary hypertension as well as studies of the impact of drug exposure on
child and family outcome. The Network also supports a registry (the
generic database or GDB) of very low birth
weight (VLBW) infants, those who are inborn and between 22 0/7 to 28 6/7 weeks (<29 weeks)
inclusive gestational age; and/or between 401 grams to 1000 grams inclusive birth weight.
The Network has a standardized Follow-up Program
of GDB infants less than or equal to 26 completed weeks GA (up to and including
26 6/7 weeks) admitted to the NICU of participating centers. Infants enrolled in a
randomized trial or approved observational study with 22-26 month follow-up as a predefined
primary or secondary outcome are also followed up at 22-26 months.
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,
, 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.