UnknownNot Applicable

Topical Coconut Oil Application and Incidence of Sepsis in Neonates

India420 participantsStarted 2021-05-15

Plain-language summary

The randomized control trial aims to determine the effect of twice daily application of a commonly used coconut oil to the skin of neonates in the neonatal intensive care setting on the rate of late onset sepsis versus a no treatment control.

Who can participate

Age range

1 Day – 3 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Late-onset sepsis rate for intervention versus control

Timeframe: Day 3 of life until discharge or day of life 28, whichever occurs first

Trial details

NCT IDNCT04842786

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-11-15

Contact for this trial

Vivek Narendran, MD

513-636-4200 vivek.narendran@cchmc.org

View on ClinicalTrials.gov More Late-Onset Neonatal Sepsis trials

Who can participate

Age range

1 Day – 3 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.