Topical Coconut Oil Application and Incidence of Sepsis in Neonates

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.

Study Overview

• Status: Recruiting
• Conditions: Late-Onset Neonatal Sepsis
• Intervention / Treatment: Other: Coconut oil

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.

• Study Type: Interventional
• Enrollment (Estimated): 420
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vivek Narendran, MD; Phone Number: 513-636-4200; Email: vivek.narendran@cchmc.org
• Study Contact Backup: Name: Marty Visscher, PhD; Phone Number: 513-746-5100; Email: visschmo@ucmail.uc.edu

Study Locations

• India
  • Bangalore, India
    • Recruiting
    • Cloudnine Hospital
    • Contact: Kishore Kumar, MBBS, MD; Email: kishkum@gmail.com
  • Bangalore, India
    • Withdrawn
    • Indira Gandhi Institute of Child Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 1 year (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: Coconut oil; Coconut oil, Parachute oil composition: 92% lauric (C12) fatty acid, 6% oleic fatty acid, 2% linoleic fatty acid
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin erythema	The skin erythema (redness) of the outer thigh and perianal region will be quantified from visual inspection of high resolution digital photographs that will be collected with standard positioning and lighting and color corrected. The area of coverage and severity of erythema will be judged using published, validated grading scales.	Day 3 of life until discharge or day of life 28, whichever comes first
Skin rash	The skin rash of the outer thigh and perianal region will be quantified from visual inspection of high resolution digital photographs that will be collected with standard positioning and lighting and color corrected. The area of coverage and severity of rash will be judged using published, validated grading scales.	Day 3 of life until discharge or day of life 28, whichever comes first
Skin dryness	The skin dryness of the outer thigh and perianal region will be quantified from visual inspection of high resolution digital photographs that will be collected with standard positioning and lighting and color corrected. The area of coverage and severity of dryness/scaling will be judged using published, validated grading scales.	Day 3 of life until discharge or day of life 28, whichever comes first
Skin transepidermal water loss	The rate of transepidermal water loss of a site on the outer thigh will be measured as grams/meter2/hour using a standard, closed-chamber instrument known as the Vapometer. This instrument will provide the transepidermal water loss value once the system reaches equilibrium. This method has previously been validated and is used routinely for skin measurements.	Day 3 of life until discharge or day of life 28, whichever comes first
Skin surface acidity (pH)	The skin surface acidity of a site on the outer thigh and a site on the buttocks covered by the diaper will be measured using a flat surface electrode device that is calibrated daily to buffers of pH 4 and pH 7. The surface acidity is given in pH units which are the negative log to the base 10 of the hydrogen ion concentration of water placed on the skin by the instrument probe. The instrument is designed for use on the skin and has been validated.	Day 3 of life until discharge or day of life 28, whichever comes first
Set of skin surface proteins of known innate immune function	There are proteins in the skin surface layers known to be biomarkers of innate immune function. Each protein will be quantified and reported as picograms of protein per microgram of total protein. The specific proteins are: filaggrin, filaggrin 2, transglutaminase 3, S100A8 (antimicrobial, calcium binding protein), S100A7 (antimicrobial, calcium binding protein), SERPINB3 (cysteine protease inhibitor), SERPINB4 (protease inhibitor), elafin (protease inhibitor) keratins 1, 6A and 6B (structural proteins) and fatty acid elongase 1 (lipid). Levels of each protein will be evaluated together to compare effect of the intervention versus control. Samples from skin surface will be collected using two sequential adhesive tapes (gentle adhesive) placed on the skin sites (thigh, buttocks covered by diaper) for one minute each, removed and stored at -80 deg C until analysis. The proteins will be extracted and analyzed for using standard techniques of tandem mass spectrometry.	Day 3 of life until discharge or day of life 28, whichever comes first
Skin Microbiome	Microbiome analyses of neonatal skin and stool to determine the effect of coconut oil versus no treatment on microflora	Day 3 of life until discharge or day of life 28, whichever comes first
Chronic lung disease	The incidence of chronic lung disease among the subjects in the intervention (coconut oil) will be compared to the incidence in the no treatment control during the study period. Chronic lung disease will be diagnosed based on the subject's oxygen requirement at 36 weeks corrected age.	Day 3 of life until discharge or day of life 28, whichever comes first
Causative Organisms of Sepsis	Sepsis diagnosis includes determination of the organisms to which sepsis was attributed	Day 3 of life until discharge or day of life 28, whichever comes first
Necrotizing enterocolitis	The impact of coconut oil versus no treatment on the incidence of necrotizing enterocolitis during the study period	Day 3 of life until discharge or day of life 28, whichever comes first.

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: University of Cincinnati; Cloudnine Hospital, Bangalore, India
• Investigators: Principal Investigator: 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

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2021
• Primary Completion (Estimated): November 15, 2025
• Study Completion (Estimated): February 15, 2026

Study Registration Dates

• First Submitted: April 2, 2021
• First Submitted That Met QC Criteria: April 9, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): September 1, 2023
• Last Update Submitted That Met QC Criteria: August 30, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: skin; imaging; biomarker; premature infant; microbiome; skin barrier; transepidermal water loss; coconut oil; late-onset neonatal sepsis; full-term infant; stratum corneum; skin surface acidity (pH); d'squame tape
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Infant, Newborn, Diseases; Sepsis; Toxemia; Neonatal Sepsis
• Other Study ID Numbers: 2020-0487 (Other Identifier: M D Anderson Cancer Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No