Topical Coconut Oil Application and Incidence of Sepsis in Neonates

Trial Information
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Am I eligible for this trial?
Participation Requirements
Sex:
All
Maximum Age:
3 days
Healthy Volunteers:
No

• 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

Where is this trial taking place?
Other Locations
India
Cloudnine Hospital
Recruiting
Bangalore
Indira Gandhi Institute of Child Health
Not yet recruiting
Bangalore
Who do I contact about this trial?
Primary
Vivek Narendran, MD
vivek.narendran@cchmc.org
513-636-4200
Backup
Marty Visscher, PhD
visschmo@ucmail.uc.edu
513-746-5100
When is this trial taking place?
Start Date: May 15, 2021
Estimated Completion Date: February 15, 2023
How many participants will be in this trial?
Target number of participants: 420
What treatment is being studied in this trial?
Experimental: Coconut oil at 5 mg/Kg body weight twice daily
Coconut oil (Parachute Brand) is a marketed product that is routinely used for daily massage after birth for infants in India. An amount of 5 mg/Kg body weight will be applied twice daily by the health care provider from enrollment until discharge, or until day of life 28, whichever occurs first.
No Intervention: No intervention
Subjects assigned to this arm will have their skin gently stroked twice daily for the time that would be required to apply an oil. This will simulate the stroking received by the intervention arm subjects. This will occur from enrollment until discharge, or until day of life 28, whichever occurs first.
Who are the authors of this trial?
Kishore Kumar, Prathik B H, Naveen Benakappa

This content was sourced from clinicaltrials.gov