Topical Coconut Oil Application and Incidence of Sepsis in Neonates

NCT ID: NCT04842786

Last Updated: 2023-09-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-15
• Study Completion Date: 2026-02-15

Brief 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.

Detailed Description

Purpose and Specific Aims

The purpose is to determine the effect of twice daily topical coconut oil application on late onset sepsis in neonates admitted to the Neonatal Intensive Care Units of Indira Gandhi Institute of Child Health, Cloudnine Hospital at Old Airport Road, and Cloudnine Hospital at Jayanagar in Bangalore, India. The aim is to determine the effect of topical coconut oil application on:

• The incidence of neonatal late onset culture positive sepsis
• Neonatal skin integrity versus a no treatment control using standard skin evaluation methods
• Biomarkers of neonatal innate immune function
• Temperature instability, weight gain, intraventricular hemorrhage, necrotizing enterocolitis, retinopathy of prematurity, chronic lung disease, and mortality.

The investigators hypothesize that twice daily topical coconut oil application will reduce the incidence of late onset sepsis (LOS) in premature and full-term infants versus the current standard of care, i.e., no treatment. The oil treatment will increase the neonatal skin barrier integrity measured by validated clinical and instrumental methods. Skin surface biomarkers of innate immune function collected from coconut oil treated skin will indicate less inflammation (lower proinflammatory cytokine levels) than in untreated control skin.

Conditions

Late-Onset Neonatal Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Coconut oil

Intervention Type: OTHER

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

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Coconut oil

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 3 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cloudnine Hospital, Bangalore, India

UNKNOWN

Sponsor Role: collaborator

University of Cincinnati

OTHER

Sponsor Role: collaborator

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Vivek Narendran, MD

Professor of Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kishore Kumar, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Cloudnine Hospital

Naveen Benakappa, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Indira Gandhi Institute of Child Health

Prathik B H, MBBS, MD

Role: PRINCIPAL_INVESTIGATOR

Indira Gandhi Institute of Child Health

Locations

Cloudnine Hospital

Bangalore, , India

Site Status: RECRUITING

Indira Gandhi Institute of Child Health

Bangalore, , India

Site Status: WITHDRAWN

Countries

India

Central Contacts

Vivek Narendran, MD

Role: CONTACT

vivek.narendran@cchmc.org

513-636-4200

Marty Visscher, PhD

Role: CONTACT

visschmo@ucmail.uc.edu

513-746-5100

Facility Contacts

Kishore Kumar, MBBS, MD

Role: primary

kishkum@gmail.com

Other Identifiers

2020-0487

Identifier Type: -

Identifier Source: org_study_id