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

September 23, 2024 updated by: Genesis Health System
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Iowa
      • Davenport, Iowa, United States, 52803
        • Genesis Medical Center, East Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 hours to 2 years (Child)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Coconut Oil
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
Active Comparator: Standard of Care
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Number of Days Free From Diaper Dermatitis
Time Frame: Once, at hospital discharge, an average of 2 weeks
The number of days free from diaper dermatitis.
Once, at hospital discharge, an average of 2 weeks
The Number of Patients Experiencing Adverse Events
Time Frame: Once, at hospital discharge, an average of 2 weeks
The number of patients experiencing adverse events.
Once, at hospital discharge, an average of 2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Percent of Parents Stating Satisfaction With the Diaper Dermatitis Treatment Used
Time Frame: Once, at study completion for hospital discharge, an average of 2 weeks
The percent of parents stating 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genesis Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

June 30, 2019

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 23, 2015

First Posted (Estimated)

November 25, 2015

Study Record Updates

Last Update Posted (Actual)

October 15, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 817035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dermatitis, Contact

Clinical Trials on Organic, Unrefined Coconut Oil

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cambodia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe