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Topical Coconut Oil Application and Incidence of Sepsis in Neonates

NCT04842786 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2023-09-01

No results posted yet for this study

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.

Conditions

  • Late-Onset Neonatal Sepsis

Interventions

OTHER

Coconut oil

Coconut oil, Parachute oil composition: 92% lauric (C12) fatty acid, 6% oleic fatty acid, 2% linoleic fatty acid

Sponsors & Collaborators

  • Cloudnine Hospital, Bangalore, India

    collaborator UNKNOWN

  • University of Cincinnati

    collaborator OTHER

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Kishore Kumar, MBBS, MD · Cloudnine Hospital

  • Naveen Benakappa, MBBS, MD · Indira Gandhi Institute of Child Health

  • Prathik B H, MBBS, MD · Indira Gandhi Institute of Child Health

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
3 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-15
Primary Completion
2025-11-15
Completion
2026-02-15

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04842786 on ClinicalTrials.gov