Back to resultsThe Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population
Primary Purpose
Dermatitis, Contact
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Organic, Unrefined Coconut Oil
Medline Remedy Phytoplex Z-Guard Skin Protectant
Sponsored by
About this trial
This is an interventional prevention trial for Dermatitis, Contact
Eligibility Criteria
Inclusion Criteria:
- Babies admitted to the Genesis NICU
- Anticipated stay in the NICU is ≥ 48 hours
- Babies wearing diapers 24 hours a day
- Parent willing to sign informed consent for the study
- Parent willing to use the test products in the diaper area during the trial
- Parent willing to not change the type or brand of diaper and wipes during the study
- 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:
- Babies with a gestational age <30 weeks
- Babies with major congenital malformations
- Active dermatological conditions other than diaper dermatitis that may affect trial results
- Known sensitivity to ingredients in trial products
- Babies whose parents have a hazelnut or coconut allergy
- Other severe acute medical conditions that may increase the risk associated with trial participation
Sites / Locations
- Genesis Medical Center, East Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Coconut Oil
Standard of Care
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
The number of days free from diaper dermatitis
The number of adverse events
Secondary Outcome Measures
The level of parent satisfaction with the diaper dermatitis treatment used
Measured by a parent satisfaction survey
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02614248
Brief Title
The Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population
Official Title
The Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2021 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genesis Health System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Contact
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Coconut Oil
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Organic, Unrefined Coconut Oil
Intervention Type
Other
Intervention Name(s)
Medline Remedy Phytoplex Z-Guard Skin Protectant
Primary Outcome Measure Information:
Title
The number of days free from diaper dermatitis
Time Frame
Once, at hospital discharge, an average of 2 weeks
Title
The number of adverse events
Time Frame
Once, at hospital discharge, an average of 2 weeks
Secondary Outcome Measure Information:
Title
The level of parent satisfaction with the diaper dermatitis treatment used
Description
Measured by a parent satisfaction survey
Time Frame
Once, at study completion for hospital discharge, an average of 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Hours
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Babies admitted to the Genesis NICU
Anticipated stay in the NICU is ≥ 48 hours
Babies wearing diapers 24 hours a day
Parent willing to sign informed consent for the study
Parent willing to use the test products in the diaper area during the trial
Parent willing to not change the type or brand of diaper and wipes during the study
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:
Babies with a gestational age <30 weeks
Babies with major congenital malformations
Active dermatological conditions other than diaper dermatitis that may affect trial results
Known sensitivity to ingredients in trial products
Babies whose parents have a hazelnut or coconut allergy
Other severe acute medical conditions that may increase the risk associated with trial participation
Facility Information:
Facility Name
Genesis Medical Center, East Campus
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population
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