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

Not Applicable

Completed

• Conditions: Dermatitis, Contact
• Interventions: Other: Medline Remedy Phytoplex Z-Guard Skin Protectant; Other: Organic, Unrefined Coconut Oil

• Registration Number: NCT02614248
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-11-16
• Study First Submitted QC: 2015-11-23
• Study First Posted: 2015-11-25
• Study Start: 2016-01
• Primary Completion: 2019-06-30
• Study Completion: 2019-06-30
• Results First Submitted: 2021-12-09
• Status Verified: 2024-09
• Results First Submitted QC: 2024-09-23
• Last Update Submitted: 2024-09-23
• Results First Posted: 2024-10-14
• Last Update Posted: 2024-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 149

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Medline Remedy Phytoplex Z-Guard Skin Protectant	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).
Coconut Oil	Organic, Unrefined 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).

Primary Outcome Measures

Name	Time	Method
The Number of Patients Experiencing Adverse Events	Once, at hospital discharge, an average of 2 weeks	The number of patients experiencing adverse events.
The Number of Days Free From Diaper Dermatitis	Once, at hospital discharge, an average of 2 weeks	The number of days free from diaper dermatitis.

Secondary Outcome Measures

Name	Time	Method
The Percent of Parents Stating Satisfaction With the Diaper Dermatitis Treatment Used	Once, at study completion for hospital discharge, an average of 2 weeks	The percent of parents stating satisfaction with the diaper dermatitis treatment used Measured by a parent satisfaction survey

Trial Locations

Locations (1)

Genesis Medical Center, East Campus; 🇺🇸 Davenport, Iowa, United States