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Topical Coconut Oil Application and Incidence of Sepsis in Neonates

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ClinicalTrials.gov Identifier: NCT04842786
Recruitment Status : Recruiting
First Posted : April 13, 2021
Last Update Posted : March 9, 2022
Sponsor:
Collaborators:
Cloudnine Hospital, Bangalore, India
Indira Gandhi Institute of Child Health, Bangalore, India
University of Cincinnati
Information provided by (Responsible Party):
Vivek Narendran, MD, Children's Hospital Medical Center, Cincinnati

Tracking Information
First Submitted Date  ICMJE April 2, 2021
First Posted Date  ICMJE April 13, 2021
Last Update Posted Date March 9, 2022
Actual Study Start Date  ICMJE May 15, 2021
Estimated Primary Completion Date November 15, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2021)		 Late-onset sepsis rate for intervention versus control [ Time Frame: Day 3 of life until discharge or day of life 28, whichever occurs first ]
Incidence of late-onset sepsis is defined as an infection that occurs on or after day 3 of life
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2021)
  • Skin erythema [ Time Frame: Day 3 of life until discharge or day of life 28, whichever comes first ]
    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.
  • Skin rash [ Time Frame: Day 3 of life until discharge or day of life 28, whichever comes first ]
    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.
  • Skin dryness [ Time Frame: Day 3 of life until discharge or day of life 28, whichever comes first ]
    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.
  • Skin transepidermal water loss [ Time Frame: Day 3 of life until discharge or day of life 28, whichever comes first ]
    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.
  • Skin surface acidity (pH) [ Time Frame: Day 3 of life until discharge or day of life 28, whichever comes first ]
    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.
  • Set of skin surface proteins of known innate immune function [ Time Frame: Day 3 of life until discharge or day of life 28, whichever comes first ]
    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.
  • Skin Microbiome [ Time Frame: Day 3 of life until discharge or day of life 28, whichever comes first ]
    Microbiome analyses of neonatal skin and stool to determine the effect of coconut oil versus no treatment on microflora
  • Chronic lung disease [ Time Frame: Day 3 of life until discharge or day of life 28, whichever comes first ]
    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.
  • Causative Organisms of Sepsis [ Time Frame: Day 3 of life until discharge or day of life 28, whichever comes first ]
    Sepsis diagnosis includes determination of the organisms to which sepsis was attributed
  • Necrotizing enterocolitis [ Time Frame: Day 3 of life until discharge or day of life 28, whichever comes first. ]
    The impact of coconut oil versus no treatment on the incidence of necrotizing enterocolitis during the study period
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Topical Coconut Oil Application and Incidence of Sepsis in Neonates
Official Title  ICMJE Topical Coconut Oil Application and Incidence of Sepsis in Neonates
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, single-blind, parallel group, controlled trial
Masking: Single (Outcomes Assessor)
Masking Description:
Subjects will be randomly assigned to receive coconut oil or no treatment using a random number scheme after stratification for gestational age group
Primary Purpose: Prevention
Condition  ICMJE Late-Onset Neonatal Sepsis
Intervention  ICMJE Other: Coconut oil
Coconut oil, Parachute oil composition: 92% lauric (C12) fatty acid, 6% oleic fatty acid, 2% linoleic fatty acid
Study Arms  ICMJE
  • 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.
    Intervention: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 9, 2021)		 420
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 15, 2023
Estimated Primary Completion Date November 15, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Day to 3 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vivek Narendran, MD 513-636-4200 vivek.narendran@cchmc.org
Contact: Marty Visscher, PhD 513-746-5100 visschmo@ucmail.uc.edu
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04842786
Other Study ID Numbers  ICMJE 2020-0487
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: There is not a plan to make IPD available.
Current Responsible Party Vivek Narendran, MD, Children's Hospital Medical Center, Cincinnati
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Cloudnine Hospital, Bangalore, India
  • Indira Gandhi Institute of Child Health, Bangalore, India
  • University of Cincinnati
Investigators  ICMJE
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
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP