Can topical coconut oil reduce late-onset sepsis in extremely preterm infants? A pragmatic cluster-randomised controlled trial protocol.

introductionInfants born before 28 weeks' gestation account for approximately 75% of neonatal morbidity and mortality. Late-onset sepsis (LOS) affects around 25% of these infants and is associated with an increased risk of adverse long-term outcomes. The topical application of coconut oil has been used for centuries in newborn care. Coconut oil is rich in saturated fatty acids, several of which have demonstrated antimicrobial properties. It is considered safe for extremely preterm infants, improves skin condition and may reduce the incidence of LOS. METHODS AND ANALYSIS: This is a pragmatic, cluster-randomised, two-arm, parallel-group, multicentre, phase III clinical trial evaluating the effect of topical coconut oil versus routine skin care on the incidence of LOS in extremely preterm infants. Participating neonatal units will be cluster-randomised, and all infants born at <28 weeks gestational age will receive either routine skin care or routine care with the addition of topical coconut oil. A minimum of 616 infants will be recruited into each treatment arm. Intention-to-treat and per-protocol analyses will be performed. ETHICS AND DISSEMINATION: Following ethical approval, patients will be recruited at participating sites under a waiver of consent with opt-out framework. The trial results will be disseminated through conferences, media sources and publication in relevant peer-reviewed journals. TRIAL REGISTRATION NUMBER: ACTRN12620001332910.