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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment Phase
Dermatitis, Contact Other: Organic, Unrefined Coconut Oil Other: Medline Remedy Phytoplex Z-Guard Skin Protectant Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population
Study Start Date : January 2016
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2022

Arm Intervention/treatment
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).
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).
Other: Medline Remedy Phytoplex Z-Guard Skin Protectant



Primary Outcome Measures :
  1. The number of days free from diaper dermatitis [ Time Frame: Once, at hospital discharge, an average of 2 weeks ]
  2. The number of adverse events [ Time Frame: Once, at hospital discharge, an average of 2 weeks ]

Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02614248


Locations
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United States, Iowa
Genesis Medical Center, East Campus
Davenport, Iowa, United States, 52803
Sponsors and Collaborators
Genesis Health System

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Responsible Party: Genesis Health System
ClinicalTrials.gov Identifier: NCT02614248    
Other Study ID Numbers: 817035
First Posted: November 25, 2015    Key Record Dates
Last Update Posted: August 1, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Dermatitis
Diaper Rash
Dermatitis, Contact
Skin Diseases
Dermatitis, Irritant
Skin Diseases, Eczematous
Protective Agents
Physiological Effects of Drugs