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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dermatitis, Contact

Intervention / Treatment
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* Other: Organic, Unrefined Coconut Oil
* Other: Medline Remedy Phytoplex Z-Guard Skin Protectant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Hours
Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coconut Oil<br>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<br> <br> |
| Active Comparator: Standard of Care<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of days free from diaper dermatitis |  | Once, at hospital discharge, an average of 2 weeks | 
| The number of adverse events |  | Once, at hospital discharge, an average of 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of parent satisfaction with the diaper dermatitis treatment used | Measured by a parent satisfaction survey | Once, at study completion for hospital discharge, an average of 2 weeks |