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

NCT02614248 | Completed Results DMC

• 1 other identifier: 817035
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

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.

Conditions

Dermatitis, Contact

Outcome Measures

Primary Outcomes (2)

• The Number of Days Free From Diaper Dermatitis

  The number of days free from diaper dermatitis.

  Once, at hospital discharge, an average of 2 weeks

• The Number of Patients Experiencing Adverse Events

  The number of patients experiencing adverse events.

  Once, at hospital discharge, an average of 2 weeks

Secondary Outcomes (1)

• The Percent of Parents Stating Satisfaction With the Diaper Dermatitis Treatment Used

  Once, at study completion for hospital discharge, an average of 2 weeks

Study Arms (2)

Coconut Oil

EXPERIMENTAL

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).

Other: Organic, Unrefined Coconut Oil

Standard of Care

ACTIVE COMPARATOR

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).

Other: Medline Remedy Phytoplex Z-Guard Skin Protectant

Interventions

Organic, Unrefined Coconut Oil OTHER

Coconut Oil

Medline Remedy Phytoplex Z-Guard Skin Protectant OTHER

Standard of Care

Eligibility Criteria

• Age: 5 Hours - 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genesis Health System: lead

Study Sites (1)

Genesis Medical Center, East Campus

Davenport, Iowa, 52803, United States

Location

MeSH Terms

Conditions

Dermatitis, Contact

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Results Point of Contact

• Title: Michelle Martin, RN
• Organization: Genesis Medical Center

MartinMi@genesishealth.com

562-421-7743

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2015
• First Posted: November 25, 2015
• Study Start: January 1, 2016
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-09

Locations

US (1)