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RESEARCH TRIANGLE PARK, N.C. – RTI International will continue supporting research efforts to improve the health of low birth weight and premature infants as part of the Neonatal Research Network.
The National Institute of Child Health and Human Development (NICHD), which funds the network, awarded RTI a five-year cooperative agreement grant, worth up to $30 million, to continue serving as the data coordinating center for the network. The award extends the work that RTI has conducted since 1998, providing statistical leadership, data management and logistical support for the network.
The Neonatal Research Network was established in 1986 to conduct multi-center clinical trials in neonatal medicine and management. The network includes a cooperative group of 18 U.S. hospitals that conduct clinical research to investigate persistent unanswered question regarding the safety and efficacy of treatment and management strategies for newborn infants.
As the data coordinating center, RTI investigators have led the statistical design for all active and planned network trials from inception through implementation. RTI also provides data management, assists in the development of study materials, and offers consultation in the areas of study design, execution and analysis.
“The studies conducted by the network have helped enhance the evidence base for neonatal medicine and have often changed clinical practice,” said Abhik Das, Ph.D., a biostatistician at RTI and the principal investigator for the network data coordinating center.
Recent studies designed and analyzed by RTI for the network have found:
- Very low birth weight Down syndrome infants are at higher risk for heart and lung disorders than are very low birth weight infants who do not have a chromosomal variation
- Higher oxygen levels improve survival in very preterm infants, but also increase the risk for eye disease
- Antenatal corticosteroid therapy for mothers of infants born at 23 to 25 weeks' gestation is associated with a lower rate of infant death or neurodevelopmental impairment at 18 to 22 months of age
- Infants who received hypothermia treatment for oxygen deficiency at birth were more likely to have survived when evaluated at ages 6 and 7 than were children who received routine care.
Ongoing studies in the network include registries for low birth-weight infants, clinical trials, observational studies, and a longitudinal study on long-term developmental outcomes.
“These and future network studies will continue to address the critical gaps that remain in neonatal research,” Das said. “This award provides RTI with the opportunity to continue to provide innovative solutions to the significant methodological challenges that exist in designing rigorous trials for neonatal studies and the design and analysis strategies to address them.”
NICHD provides programmatic oversight, coordination and assistance to the network with other co-sponsoring National Institutes of Health participating in specific research studies.
