Topical Coconut Oil Application and Incidence of Sepsis in Neonates

NCT04842786 | Recruiting

• 1 other identifier: 2020-0487
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 2

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.

Conditions

Late-Onset Neonatal Sepsis

Keywords

late-onset neonatal sepsis; premature infant; full-term infant; skin; skin barrier; biomarker; stratum corneum; skin surface acidity (pH); transepidermal water loss; imaging; d'squame tape; microbiome; coconut oil

Outcome Measures

Primary Outcomes (1)

• Late-onset sepsis rate for intervention versus control

  Incidence of late-onset sepsis is defined as an infection that occurs on or after day 3 of life

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

Secondary Outcomes (10)

• Skin erythema

  Day 3 of life until discharge or day of life 28, whichever comes first

• Skin rash

  Day 3 of life until discharge or day of life 28, whichever comes first

• Skin dryness

  Day 3 of life until discharge or day of life 28, whichever comes first

• Skin transepidermal water loss

  Day 3 of life until discharge or day of life 28, whichever comes first

• Skin surface acidity (pH)

  Day 3 of life until discharge or day of life 28, whichever comes first

Study Arms (2)

Coconut oil at 5 mg/Kg body weight twice daily

EXPERIMENTAL

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.

Other: Coconut oil

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.

Interventions

Coconut oil OTHER

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

Coconut oil at 5 mg/Kg body weight twice daily

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital Medical Center, Cincinnati: lead
• Cloudnine Hospital, Bangalore, India: collaborator
• University of Cincinnati: collaborator

Study Sites (2)

Cloudnine Hospital

Bangalore, India

RECRUITING

Indira Gandhi Institute of Child Health

Bangalore, India

WITHDRAWN

MeSH Terms

Conditions

Neonatal Sepsis; Premature Birth

Interventions

Coconut Oil

Condition Hierarchy (Ancestors)

Sepsis; Infections; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats; Fats; Lipids; Plant Oils; Oils

Study Officials

• Kishore Kumar, MBBS, MD

  Cloudnine Hospital

  PRINCIPAL INVESTIGATOR

• Naveen Benakappa, MBBS, MD

  Indira Gandhi Institute of Child Health

  PRINCIPAL INVESTIGATOR

• Prathik B H, MBBS, MD

  Indira Gandhi Institute of Child Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vivek Narendran, MD

CONTACT

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

Marty Visscher, PhD

CONTACT

513-746-5100; visschmo@ucmail.uc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Subjects will be randomly assigned to receive coconut oil or no treatment using a random number scheme after stratification for gestational age group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Model Details: Randomized, single-blind, parallel group, controlled trial

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 13, 2021
• Study Start: May 15, 2021
• Primary Completion: November 15, 2025
• Study Completion: February 15, 2026
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)