Early Childhood Neurodevelopmental, Economic and Nutritional Outcomes among Former Very Low Birth Weight Infants from the Reducing Disparity in Mother's Own Milk (ReDiMOM) Trial - Project Summary Although most very preterm (VP; <32 weeks gestation) infants survive to discharge from the neonatal intensive care unit (NICU), they remain at heightened risk for impaired neurodevelopment (ND), obesity and cardiometabolic conditions, burdening families and translating to high healthcare costs over the lifespan. One strategy to reduce these risks is to feed mother’s own milk (MOM) during the NICU hospitalization, because MOM is associated with a dose-dependent enhancement in early brain development, better ND outcomes, and a reduced risk of obesity and its complications. Observational studies have documented health and economic benefits associated with MOM, but all of these studies have been limited by the inability to ethically randomize VP infants to receive different doses of MOM. Although exclusive MOM feedings through the first 6 months of life are recommended for all infants, mothers of VP infants face numerous barriers in providing MOM. Almost 50% of mothers discontinue MOM provision before NICU discharge, well before their infants reach 6 months of age. Our ongoing NIH-funded randomized controlled trial, “Reducing disparity in the receipt of mother’s own milk in very low birthweight infants: An economic intervention” (ReDiMOM, R01MD013969) was designed to test the effectiveness of an economic intervention that covers the maternal costs of providing MOM in the NICU. ReDiMOM provides an economic bundle to intervention group mothers: free hospital grade electric breast pump rental, free pickup of pumped MOM from the home, and payment for each day spent pumping to offset maternal opportunity costs. Both intervention and control group mothers receive standard NICU-specific lactation care. This ethical randomization of an intervention to achieve higher NICU MOM doses in the intervention group provides the first opportunity to obtain experimental evidence of MOM’s impact on health and economic outcomes in early childhood. Leveraging the randomized design of ReDiMOM, the overall aim of this study is to assess ND (cognitive, language and motor index scores), adiposity, and duration of MOM feedings, total cost of care and cost-effectiveness through 20 months’ corrected age, without residual confounding concerns. Additionally, this study will assess the relationship between total duration of MOM feeding (in NICU and post discharge) and early childhood outcomes using a robust cohort design. This study provides an unparalleled opportunity to obtain experimental evidence of the effect of MOM feedings on early childhood ND and adiposity in VP infants without unmeasured confounding. It will provide the highest quality of evidence for decision makers and essential economic data needed to compare the two NICU lactation strategies employed in ReDiMOM. The impact will be on prioritizing investment in effective strategies that support MOM for VP infants and reduce inequities in the receipt of MOM, ultimately leading to improved outcomes for all VP infants.
