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

Dermatitis, Contact Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02614248
• Other study ID #: 817035
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2022

Study information

• Verified date: July 2019
• Source: Genesis Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: January 2022
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Contact
• Diaper Rash

Intervention

Other:
• Organic, Unrefined Coconut Oil

• Medline Remedy Phytoplex Z-Guard Skin Protectant

Locations

Country	Name	City	State
United States	Genesis Medical Center, East Campus	Davenport	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Genesis Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of days free from diaper dermatitis		Once, at hospital discharge, an average of 2 weeks
Primary	The number of adverse events		Once, at hospital discharge, an average of 2 weeks
Secondary	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