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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2021

Interventions

  • Other: Organic, Unrefined Coconut Oil
  • Other: Medline Remedy Phytoplex Z-Guard Skin Protectant

Arms, Groups and Cohorts

  • 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).
  • 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).

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 5 Hours

Maximum Age: 2 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Genesis Health System
  • Provider of Information About this Clinical Study
    • Sponsor

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