A request for applications (RFA) is proposed entitled: Data Coordinating Center for the Cooperative Multicenter Neonatal Research Network. This proposed RFA will use the cooperative agreement mechanism. This network has received support from other Institutes for ongoing and upcoming studies. National Heart, Lung and Blood Institute have provided capitation costs for the Transfusion of Prematures (TOP) trial, NEI is currently support the Inositol for Retinopathy studies, and the CDC is supporting an early onset sepsis surveillance study.
Purpose
The purpose of this request is to re-compete the clinical centers for the Neonatal Research Network. The network consists of clinical sites of neonatal intensive care units, an independent datacenter and NICHD to perform clinical trials and observational research. The goal of the Neonatal Research Network is to advance the field of Neonatal-Perinatal by establishing and maintaining a network of academic centers that perform multi-center clinical trials in a rigorous manner to assess safety and efficacy of treatment and management strategies for newborn infants. Treatment strategies include drugs and devices requiring multicenter studies for study.
Scope
Proposals considered responsive to this solicitation include neonatal intensive care clinical centers with at least 500 admissions per year with no more than 30% outborn population. The center must have an established follow up program with a designated facility in place at the institution. The study site must have an established neonatal/perinatal data system, and a full time clinical research coordinator. Clinical sites will be required to propose a concept protocol for implementation at all of the network sites. Specifically, the network will continue to conduct prospective randomized trials of neonatal therapies and interventions, observational studies including those involving very low birth weight infants, and performing long term follow up on high risk cohorts. The proposed network would include 16-20 clinical sites, an independent data-coordinating center funded for five years in 2013, and NICHD.
Objective
The objective of this concept is to foster multicenter clinical trials in the neonatal population. The infrastructure is set up for randomized double-blind placebo controlled trials with the ability to follow short term (clinical effect) and long term (neurodevelopmental outcome) measures for the high risk neonatal population. The goal of the Neonatal Research Network is to advance the field of Neonatal-Perinatal by establishing and maintaining a network of academic centers that perform multi-center clinical trials in a rigorous manner to assess safety and efficacy of treatment and management strategies for newborn infants. Treatment strategies include drugs and devices requiring multicenter studies for study. The data coordinating center plays a pivotal role in data management and analysis, statistical expertise, and logistical services required for the neonatal research network.
Program Contact:
Tonse N.K. Raju, MD
Pregnancy and Perinatology Branch
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