Can topical coconut oil reduce late-onset sepsis in extremely preterm infants? – a pragmatic cluster-randomised controlled trial
Investigators: Tobias Strunk (Co-ordinating Principal Investigator), Jenny Mountain (Project Manager)
Extremely preterm infants, born less than 28 weeks gestation, account for 75% of newborn death and disability. Late-onset sepsis or blood stream infection affects 25-50% of these extremely preterm infants.
Recent studies have shown that coconut oil improves the skin condition in preterm infants and may reduce sepsis. Coconut oil has been used for centuries for newborns and has been demonstrated as safe to use for skin care in extremely preterm infants. Coconut oil has known antibacterial properties.
The COSI-2 trial aims to evaluate the effect of coconut oil when used for skin care in extremely preterm infants on the development of sepsis.
Hospital neonatal units from Australia and New Zealand are participating in the COSI-2 trial. All participating neonatal units are members of the Australian and New Zealand Neonatal Network. The study is a pragmatic, cluster-randomised, 2-arm, parallel, multicentre, phase III clinical trial.
Participating neonatal units are randomly allocated in a 1:1 ratio, stratified by number of infants <28 weeks gestation and incidence of late-onset sepsis, to the intervention or control arm of the study. At the intervention sites, all infants born <28 weeks gestation will receive coconut oil for skin care according to the study protocol. Infants cared for in the control sites will continue to receive routine skin care.
Confirming the hypothesis that coconut oil can reduce sepsis in preterm babies would be a paradigm change for neonatal skin care. This simple, safe and highly cost-effective intervention would be readily introduced as routine care.
ANZCTR registration: ACTRN12620001332910p
Funded by the Thrasher Foundation
Download the COSI-2 Information brochure