Topical Coconut Oil Application and Incidence of Sepsis in Neonates

Late-Onset Neonatal Sepsis Clinical Trial

Official title:

Topical Coconut Oil Application and Incidence of Sepsis in Neonates

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04842786
• Other study ID #: 2020-0487
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2021
• Est. completion date: February 15, 2026

Study information

• Verified date: August 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: Vivek Narendran, MD
• Phone: 513-636-4200
• Email: vivek.narendran[@]cchmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 420
• Est. completion date: February 15, 2026
• Est. primary completion date: November 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 3 Days

Eligibility

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

Related Conditions & MeSH terms

• Late-Onset Neonatal Sepsis
• Neonatal Sepsis
• Sepsis
• Toxemia

Intervention

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

Locations

Country	Name	City	State
India	Cloudnine Hospital	Bangalore
India	Indira Gandhi Institute of Child Health	Bangalore

Sponsors (3)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	Cloudnine Hospital, Bangalore, India, University of Cincinnati

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.