Expired Study
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Davenport, Iowa 52803


Purpose:

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.


Criteria:

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 is Available At:


Original ID:

817035


NCT ID:

NCT02614248


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Active, not recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

2 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Genesis Health System


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

150


Enrollment Type:

Anticipated


Study Dates

Start Date:January 2016
Completion Date:January 2022
Completion Type:Anticipated
Primary Completion Date:January 2021
Primary Completion Type:Anticipated
Verification Date:July 2019
Last Changed Date:July 30, 2019
First Received Date:November 16, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:The number of days free from diaper dermatitis
Time Frame:Once, at hospital discharge, an average of 2 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:The number of adverse events
Time Frame:Once, at hospital discharge, an average of 2 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:The level of parent satisfaction with the diaper dermatitis treatment used
Time Frame:Once, at study completion for hospital discharge, an average of 2 weeks
Safety Issues:False
Description:Measured by a parent satisfaction survey

Study Interventions

Intervention Type:Other
Name:Organic, Unrefined Coconut Oil
Arm Name:Coconut Oil
Intervention Type:Other
Name:Medline Remedy Phytoplex Z-Guard Skin Protectant
Arm Name:Standard of Care

Study Arms

Study Arm Type:Experimental
Arm Name:Coconut Oil
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).
Study Arm Type:Active Comparator
Arm Name:Standard of Care
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 t

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Genesis Health System

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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