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

Genesis Health System

Status: Completed

Conditions: Dermatitis, Contact

Treatments: Other: Organic, Unrefined Coconut Oil; Other: Medline Remedy Phytoplex Z-Guard Skin Protectant

Study type: Interventional

Funder types: Other

Identifiers

NCT02614248

817035

Details and patient eligibility

About

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.

Enrollment: 149 patients

Sex: All

Ages: 5 hours to 2 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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149 participants in 2 patient groups

Coconut Oil

Experimental group

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).

Treatment:

Other: Organic, Unrefined Coconut Oil

Standard of Care

Active Comparator group

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).

Treatment:

Other: Medline Remedy Phytoplex Z-Guard Skin Protectant