N/A
N=149
The Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population
Dermatitis, Contact
Bottom Line
View on ClinicalTrials.gov: NCT02614248 ↗Enrolled (actual)
149
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: The Number of Days Free From Diaper Dermatitis — 4.065; 4.274 Days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Organic, Unrefined Coconut Oil (Other); Medline Remedy Phytoplex Z-Guard Skin Protectant (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Genesis Health System
- Primary completion
- Jun 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Days Free From Diaper Dermatitis |
4.065; 4.274 | — |
| PRIMARY The Number of Patients Experiencing Adverse Events |
29; 22 | — |
| SECONDARY The Percent of Parents Stating Satisfaction With the Diaper Dermatitis Treatment Used |
60; 55 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02614248). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.