Using coconut oil on the skin to reduce sepsis in newborns
Topical Coconut Oil Application and Incidence of Sepsis in Neonates
This study is testing if putting coconut oil on the skin of newborns in intensive care can help prevent infections and improve their health compared to babies who don’t get the treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 420 (estimated) |
| Ages | 1 Day to 3 Days |
| Sex | All |
| Sponsor | Children's Hospital Medical Center, Cincinnati Academic / other |
| Locations | 2 sites (Bangalore and 1 other locations) |
| Trial ID | NCT04842786 on ClinicalTrials.gov |
What this trial studies
This randomized control trial investigates the impact of applying coconut oil twice daily to the skin of neonates in neonatal intensive care units to see if it reduces the incidence of late-onset sepsis compared to a control group receiving no treatment. The study will evaluate various outcomes, including skin integrity, biomarkers of immune function, and other health indicators such as weight gain and temperature stability. The research is conducted at multiple hospitals in Bangalore, India, focusing on both premature and full-term infants who are less than 48 hours old at enrollment.
Who should consider this trial
Good fit: Ideal candidates include premature infants aged 24-36 weeks and full-term infants aged 37-42 weeks who are less than 48 hours old and admitted to the neonatal intensive care unit.
Not a fit: Patients who are medically unstable, have inherited skin conditions, major congenital anomalies, or are undergoing surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly lower the rates of late-onset sepsis in vulnerable neonates, improving their overall health outcomes.
How similar studies have performed: While the use of topical treatments in neonates is common, this specific application of coconut oil for preventing late-onset sepsis is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Premature infants 24-36 weeks gestational age * Full-term infants 37-42 weeks gestational age * Less than 48 hours of age at enrollment * Admitted to the neonatal intensive care unit of Indira Gandhi Institute for Child Health, Cloudnine Hospital at Old Airport Road and Cloudnine Hospital at Jayangar, Bangalore * Expected to be in the neonatal intensive care unit for at least 4 days after enrollment * Able to tolerate study procedures as described * Parent/guardian willing to provide written informed consent Exclusion Criteria: * Medically unstable * Parent/guardian unable to provide written informed consent * Presence of inherited cutaneous condition e.g., scalded skin syndrome, epidermolysis bullosa * Presence of major congenital anomalies * Infants undergoing surgery
Where this trial is running
Bangalore and 1 other locations
- Cloudnine Hospital — Bangalore, India (Recruiting)
- Indira Gandhi Institute of Child Health — Bangalore, India (Withdrawn)
Study contacts
- Principal investigator: Kishore Kumar, MBBS, MD — Cloudnine Hospital
- Study coordinator: Vivek Narendran, MD
- Email: vivek.narendran@cchmc.org
- Phone: 513-636-4200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.