Project Details

Repurposing prenatal sulfadoxine-pyrimethamine to prevent small vulnerable newborns globally

Holger Unger, MBChB, DTM&H, MSc, PhD

Summary

BACKGROUND: Small vulnerable newborns (SVNs) – infants born preterm and/or small-for-gestational age - experience poorer health outcomes in childhood and later life. Observational data suggests that sulfadoxine-pyrimethamine (SP), a combination antimicrobial used for intermittent preventive treatment of malaria in pregnancy (IPTp), may reduce these risks through non-malarial effects. GAP: To overcome the biases inherent in observational studies, a randomized controlled trial conducted in a non–malaria-endemic setting is needed to establish whether IPTp with SP reduces the risk of SVNs through non-malarial pathways. Such a trial should be accompanied by mechanistic investigations to further define SP’s non-malarial mode(s) of action. HYPOTHESIS: We hypothesize that monthly IPTp-SP, given from the second trimester until birth, will reduce the risk of SVNs by approximately one-third compared with placebo in a region of Bangladesh characterized by high burdens of maternal undernutrition and SVNs and no malaria transmission. METHODS: Leveraging an existing demographic surveillance system, we will randomize eligible pregnant women with singleton pregnancies in Dhaka, Bangladesh, to receive either monthly IPTp-SP from 14 weeks’ gestation until birth or a matching placebo. Women and their infants will be followed monthly until six weeks postpartum to monitor adverse events, assess maternal and infant anthropometry and hemoglobin levels, document birth outcomes, and collect samples for mechanistic analyses. RESULTS: Pending. IMPACT: Study findings will establish whether IPTp with SP can be repurposed to prevent SVNs in areas without malaria transmission.