Topical coconut oil to prevent late-onset sepsis in extremely preterm infants: a cluster-randomized clinical trial
Tobias Strunk, MD, PhD, FRACP
BACKGROUND: Despite improved survival, infants born before 28weeks gestation account for 75% of neonatal morbidity and mortality. Late-onset sepsis remains one of the most common complications among infants born extremely preterm (~25-30%) and increases both immediate illness and death as well as long-term disability.
GAP: There is an urgent need for a safe, feasible and effective intervention to reduce the burden of late-onset sepsis in preterm infants.
HYPOTHESIS: That topical coconut oil reduces the incidence of late-onset sepsis in preterm infants born <28weeks gestation.
METHODS: We will evaluate the effects of topical coconut oil administration on the incidence of late-onset sepsis (primary outcome) in extremely preterm infants in a cluster-randomized clinical trial within the Australia and New Zealand Neonatal Network. This clinical trial will have a total sample size of n=1232 (n=616 per arm).
Secondary outcomes: neonatal morbidity and mortality before hospital discharge.
Tertiary outcome: cost-effectiveness analysis of the study intervention.
IMPACT: Topical coconut oil has immediate translational potential as a safe, simple and highly affordable (<$5 per infant/week) intervention to prevent late-onset sepsis and may substantially reduce the human and economic cost of this common complication of preterm birth.