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The Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population

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ClinicalTrials.gov Identifier: NCT02614248
Recruitment Status : Active, not recruiting
First Posted : November 25, 2015
Last Update Posted : August 1, 2019
Sponsor:
Information provided by (Responsible Party):
Genesis Health System

Tracking Information
First Submitted Date  ICMJE November 16, 2015
First Posted Date  ICMJE November 25, 2015
Last Update Posted Date August 1, 2019
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 23, 2015)
  • The number of days free from diaper dermatitis [ Time Frame: Once, at hospital discharge, an average of 2 weeks ]
  • The number of adverse events [ Time Frame: Once, at hospital discharge, an average of 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 23, 2015)
The level of parent satisfaction with the diaper dermatitis treatment used [ Time Frame: Once, at study completion for hospital discharge, an average of 2 weeks ]
Measured by a parent satisfaction survey
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 The Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population
Official Title  ICMJE The Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population
Brief Summary The purpose of the study is to examine the safety and effectiveness of the use of coconut oil for the prevention and treatment of diaper dermatitis among NICU babies at Genesis Medical Center, Davenport.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Dermatitis, Contact
Intervention  ICMJE
  • Other: Organic, Unrefined Coconut Oil
  • Other: Medline Remedy Phytoplex Z-Guard Skin Protectant
Study Arms  ICMJE
  • Experimental: Coconut Oil
    Participants in this group will receive a generous layer of organic, unrefined coconut oil applied to the diaper area (buttocks and creases between thighs and hips) at each diaper change. This will continue until the patient is discharged or reaches the primary safety endpoint (skin that is eroded and/or blistered in the diaper area with bleeding).
    Intervention: Other: Organic, Unrefined Coconut Oil
  • Active Comparator: Standard of Care
    Participants in this group will receive the standard of care for preventing and treating diaper dermatitis at Genesis. This includes no treatment until a diaper dermatitis appears. If diaper dermatitis appears, participants will receive a generous layer of Medline Remedy Phytoplex Z-Guard Skin Protectant applied to the diaper area (buttocks and creases between thighs and hips) at each diaper change. This will continue until the patient is discharged or reaches the primary safety endpoint (skin that is eroded and/or blistered in the diaper area with bleeding).
    Intervention: Other: Medline Remedy Phytoplex Z-Guard Skin Protectant
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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: November 23, 2015)
150
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2022
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Babies admitted to the Genesis NICU
  2. Anticipated stay in the NICU is ≥ 48 hours
  3. Babies wearing diapers 24 hours a day
  4. Parent willing to sign informed consent for the study
  5. Parent willing to use the test products in the diaper area during the trial
  6. Parent willing to not change the type or brand of diaper and wipes during the study
  7. Parent willing to refrain from changing any other products whose use may have an effect of their baby's skin condition during the trial

Exclusion Criteria:

  1. Babies with a gestational age <30 weeks
  2. Babies with major congenital malformations
  3. Active dermatological conditions other than diaper dermatitis that may affect trial results
  4. Known sensitivity to ingredients in trial products
  5. Babies whose parents have a hazelnut or coconut allergy
  6. Other severe acute medical conditions that may increase the risk associated with trial participation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 2 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02614248
Other Study ID Numbers  ICMJE 817035
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genesis Health System
Study Sponsor  ICMJE Genesis Health System
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Genesis Health System
Verification Date July 2019

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