CompletedNot Applicable

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

United States149 participantsStarted 2016-01

Plain-language 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.

Who can participate

Age range5 Hours – 2 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

The Number of Days Free From Diaper Dermatitis

Timeframe: Once, at hospital discharge, an average of 2 weeks

The Number of Patients Experiencing Adverse Events

Timeframe: Once, at hospital discharge, an average of 2 weeks

Trial details

NCT IDNCT02614248

SponsorGenesis Health System

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-30

Results submitted2021-12-09

View on ClinicalTrials.gov More Dermatitis, Contact trials