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Can topical coconut oil reduce late-onset sepsis in extremely preterm infants? A pragmatic cluster-randomised
Tobias Strunk1,2, Jennifer Mountain3,2, Adrienne Gordon4
1Neonatology, Government of Western Australia Child and Adolescent Health Service, Subiaco, Western Australia, Australia tobias.strunk@health.wa.gov.au.
Insights
Topical coconut oil may reduce late-onset sepsis (LOS) in extremely preterm infants. This clinical trial investigates its effectiveness compared to routine skin care for improving neonatal outcomes.
Area of Science:
- Neonatalogy
- Dermatology
- Infectious Diseases
Background:
- Extremely preterm infants (<28 weeks gestation) face high neonatal morbidity and mortality.
- Late-onset sepsis (LOS) affects 25% of these infants, increasing long-term adverse outcomes.
- Topical coconut oil, rich in antimicrobial fatty acids, is safe for preterm infants and may improve skin health.
Purpose of the Study:
- To evaluate the efficacy of topical coconut oil in reducing the incidence of late-onset sepsis (LOS) in extremely preterm infants.
- To compare outcomes between infants receiving routine skin care and those receiving routine care with topical coconut oil.
Main Methods:
- A pragmatic, cluster-randomised, phase III clinical trial involving multiple centers.
- Recruitment of at least 616 extremely preterm infants per arm (<28 weeks gestational age).
- Intention-to-treat and per-protocol analyses will be conducted.
Main Results:
- This section is not available in the provided abstract.
Conclusions:
- This section is not available in the provided abstract.
Introduction:
Infants 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.
