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Topical Coconut Oil Application and Incidence of Sepsis in Neonates

Primary Purpose

Late-Onset Neonatal Sepsis

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Coconut oil
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Late-Onset Neonatal Sepsis focused on measuring 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

Eligibility Criteria

1 Day - 3 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cloudnine HospitalRecruiting
  • Indira Gandhi Institute of Child Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Coconut oil at 5 mg/Kg body weight twice daily

No intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Skin Microbiome
Microbiome analyses of neonatal skin and stool to determine the effect of coconut oil versus no treatment on microflora
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.
Causative Organisms of Sepsis
Sepsis diagnosis includes determination of the organisms to which sepsis was attributed
Necrotizing enterocolitis
The impact of coconut oil versus no treatment on the incidence of necrotizing enterocolitis during the study period

Full Information

First Posted
April 2, 2021
Last Updated
August 30, 2023
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Cloudnine Hospital, Bangalore, India, University of Cincinnati
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1. Study Identification

Unique Protocol Identification Number
NCT04842786
Brief Title
Topical Coconut Oil Application and Incidence of Sepsis in Neonates
Official Title
Topical Coconut Oil Application and Incidence of Sepsis in Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2021 (Actual)
Primary Completion Date
November 15, 2025 (Anticipated)
Study Completion Date
February 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Cloudnine Hospital, Bangalore, India, University of Cincinnati

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, single-blind, parallel group, controlled trial
Masking
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
Allocation
Randomized
Enrollment
420 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Coconut oil at 5 mg/Kg body weight twice daily
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Coconut oil
Intervention Description
Coconut oil, Parachute oil composition: 92% lauric (C12) fatty acid, 6% oleic fatty acid, 2% linoleic fatty acid
Primary Outcome Measure Information:
Title
Late-onset sepsis rate for intervention versus control
Description
Incidence of late-onset sepsis is defined as an infection that occurs on or after day 3 of life
Time Frame
Day 3 of life until discharge or day of life 28, whichever occurs first
Secondary Outcome Measure Information:
Title
Skin erythema
Description
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.
Time Frame
Day 3 of life until discharge or day of life 28, whichever comes first
Title
Skin rash
Description
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.
Time Frame
Day 3 of life until discharge or day of life 28, whichever comes first
Title
Skin dryness
Description
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.
Time Frame
Day 3 of life until discharge or day of life 28, whichever comes first
Title
Skin transepidermal water loss
Description
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.
Time Frame
Day 3 of life until discharge or day of life 28, whichever comes first
Title
Skin surface acidity (pH)
Description
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.
Time Frame
Day 3 of life until discharge or day of life 28, whichever comes first
Title
Set of skin surface proteins of known innate immune function
Description
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.
Time Frame
Day 3 of life until discharge or day of life 28, whichever comes first
Title
Skin Microbiome
Description
Microbiome analyses of neonatal skin and stool to determine the effect of coconut oil versus no treatment on microflora
Time Frame
Day 3 of life until discharge or day of life 28, whichever comes first
Title
Chronic lung disease
Description
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.
Time Frame
Day 3 of life until discharge or day of life 28, whichever comes first
Title
Causative Organisms of Sepsis
Description
Sepsis diagnosis includes determination of the organisms to which sepsis was attributed
Time Frame
Day 3 of life until discharge or day of life 28, whichever comes first
Title
Necrotizing enterocolitis
Description
The impact of coconut oil versus no treatment on the incidence of necrotizing enterocolitis during the study period
Time Frame
Day 3 of life until discharge or day of life 28, whichever comes first.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vivek Narendran, MD
Phone
513-636-4200
Email
vivek.narendran@cchmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Marty Visscher, PhD
Phone
513-746-5100
Email
visschmo@ucmail.uc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kishore Kumar, MBBS, MD
Organizational Affiliation
Cloudnine Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naveen Benakappa, MBBS, MD
Organizational Affiliation
Indira Gandhi Institute of Child Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Prathik B H, MBBS, MD
Organizational Affiliation
Indira Gandhi Institute of Child Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cloudnine Hospital
City
Bangalore
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kishore Kumar, MBBS, MD
Email
kishkum@gmail.com
Facility Name
Indira Gandhi Institute of Child Health
City
Bangalore
Country
India
Individual Site Status
Withdrawn

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is not a plan to make IPD available.

Learn more about this trial

Topical Coconut Oil Application and Incidence of Sepsis in Neonates

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