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RTI contributes to clinical trial finding donor milk results in fewer intestinal complications than formula among preterm infants

RTI researchers provided critical support for the study as the data coordinating center

RESEARCH TRIANGLE PARK, N.C. – Researchers at RTI International, a nonprofit research institute, have contributed to a new randomized clinical trial on preterm infants that found that compared to their formula-fed counterparts, extremely preterm infants fed donated human milk had half the rate of necrotizing enterocolitis, a common life-threatening condition of the intestines.

The study, published in the Journal of the American Medical Association (JAMA), was led by Iowa University’s Carver College of Medicine and included colleagues at all 15 academic medical centers of the Neonatal Research Network (NRN), for which RTI serves as the Data Coordinating Center (DCC). The network is part of NIH’s Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).

The research team randomly assigned 483 preterm to receive formula or donated human milk. Infants were fed these diets until they were discharged, died or reached 120 days of age, whichever came first. Necrotizing enterocolitis was identified in 10 infants in the donor milk group, compared to 22 infants in the formula group.

The authors concluded that donor human milk, similar to maternal milk, can reduce the risk of necrotizing enterocolitis compared to formula. They also noted that neurodevelopmental outcomes at two years of age did not differ between the two groups.  

As the DCC for the NRN, a role RTI has held since 1998, RTI experts provided biostatistical leadership, data management and logistical coordination for the study.

RTI has supported more than 400 NRN peer reviewed publications aimed at understanding and improving clinical care for sick newborns. Findings from these studies have led to changes in care practices and improved outcomes for high-risk infants.

View the full study (via JAMA)

Read related editorial: Delivering on the promise of human milk for extremely preterm infants in the NICU (via JAMA)

Read related NICHD press release

Learn more about RTI’s role in the Neonatal Research Network