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History of Changes for Study: NCT02614248
The Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population
Latest version (submitted July 30, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 23, 2015 None (earliest Version on record)
2 May 6, 2016 Recruitment Status, Study Status, Contacts/Locations and Oversight
3 August 1, 2018 Contacts/Locations and Study Status
4 July 30, 2019 Recruitment Status, Study Status, Contacts/Locations
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Study NCT02614248
Submitted Date:  November 23, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: 817035
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
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2015
Overall Status: Not yet recruiting
Study Start: December 2015
Primary Completion: January 2018 [Anticipated]
Study Completion: July 2018 [Anticipated]
First Submitted: November 16, 2015
First Submitted that
Met QC Criteria:
November 23, 2015
First Posted: November 25, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 23, 2015
Last Update Posted: November 25, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Genesis Health System
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
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.
Detailed Description:
Open or close this module Conditions
Conditions: Dermatitis, Contact
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Prevention
Study Phase: Not Applicable
Interventional Study Model: Parallel Assignment
Number of Arms: 2
Masking: None (Open Label)
Allocation: Randomized
Enrollment: 150 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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).
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).
Medline Remedy Phytoplex Z-Guard Skin Protectant
Open or close this module Outcome Measures
Primary Outcome Measures:
1. The number of days free from diaper dermatitis
[ Time Frame: Once, at hospital discharge, an average of 2 weeks ]

2. The number of adverse events
[ Time Frame: Once, at hospital discharge, an average of 2 weeks ]

Secondary Outcome Measures:
1. 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 ]

Measured by a parent satisfaction survey
Open or close this module Eligibility
Minimum Age: 5 Hours
Maximum Age: 2 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Sarah Castro, MPH
Telephone: 563-421-7957
Email: castros@genesishealth.com
Locations: United States, Iowa
Genesis Medical Center, East Campus
Davenport, Iowa, United States, 52803
Contact:Contact: Sarah Castro, MPH 563-421-7957 castros@genesishealth.com
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