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History of Changes for Study: NCT04842786
Topical Coconut Oil Application and Incidence of Sepsis in Neonates
Latest version (submitted March 7, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 April 9, 2021 None (earliest Version on record)
2 March 7, 2022 Recruitment Status, Study Status and Contacts/Locations
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Study NCT04842786
Submitted Date:  April 9, 2021 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2020-0487
Brief Title: Topical Coconut Oil Application and Incidence of Sepsis in Neonates
Official Title: Topical Coconut Oil Application and Incidence of Sepsis in Neonates
Secondary IDs:
Open or close this module Study Status
Record Verification: April 2021
Overall Status: Not yet recruiting
Study Start: April 15, 2021
Primary Completion: November 15, 2022 [Anticipated]
Study Completion: February 15, 2023 [Anticipated]
First Submitted: April 2, 2021
First Submitted that
Met QC Criteria:
April 9, 2021
First Posted: April 13, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:
April 9, 2021
Last Update Posted: April 13, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Children's Hospital Medical Center, Cincinnati
Responsible Party: Principal Investigator
Investigator: Vivek Narendran, MD
Official Title: Professor of Pediatrics
Affiliation: Children's Hospital Medical Center, Cincinnati
Collaborators: Cloudnine Hospital, Bangalore, India
Indira Gandhi Institute of Child Health, Bangalore, India
University of Cincinnati
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring: No
Open or close this module 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.

Open or close this module Conditions
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
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Randomized, single-blind, parallel group, controlled trial
Number of Arms: 2
Masking: Single (Outcomes Assessor)
Allocation: Randomized
Enrollment: 420 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.
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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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
Secondary Outcome Measures:
1. 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.
2. 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.
3. 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.
4. 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.
5. 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.
6. 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.

7. 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
8. 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.
9. 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
10. 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
Open or close this module Eligibility
Minimum Age: 1 Day
Maximum Age: 3 Days
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Vivek Narendran, MD
Telephone: 513-636-4200
Email: vivek.narendran@cchmc.org
Central Contact Backup: Marty Visscher, PhD
Telephone: 513-746-5100
Email: visschmo@ucmail.uc.edu
Study Officials: Kishore Kumar, MBBS, MD
Principal Investigator
Cloudnine Hospital
Naveen Benakappa, MBBS, MD
Principal Investigator
Indira Gandhi Institute of Child Health
Prathik B H, MBBS, MD
Principal Investigator
Indira Gandhi Institute of Child Health
Locations: India
Cloudnine Hospital
Bangalore, India
Contact:Contact: Kishore Kumar, MBBS, MD kishkum@gmail.com
Indira Gandhi Institute of Child Health
Bangalore, India
Contact:Contact: Naveen Benakappa, MBBS, MD navaga55@yahoo.com
Open or close this module IPDSharing
Plan to Share IPD: No
There is not a plan to make IPD available.
Open or close this module References
Citations:
Links:
Available IPD/Information:

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