NICHD Neonatal Research Network Search
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NICHD Neonatal Research Network Background and Overview
In 1986, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), 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.

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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 18 -22 month follow-up as a predefined primary or secondary outcome are also followed up at 18-22 months.

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Clinical Centers
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 training.

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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.

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NICHD Staff
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.

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Steering Committee
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.

 

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