Dermatitis, ContactNCT02614248
The Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population
A study testing Organic, Unrefined Coconut Oil and Medline Remedy Phytoplex Z-Guard Skin Protectant in people with Dermatitis, Contact, run by Genesis Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 5 hours to 2 years
- Conditions the study is for
- Dermatitis, Contact
- What is being tested?
- Organic, Unrefined Coconut Oil and Medline Remedy Phytoplex Z-Guard Skin Protectant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 hours to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Genesis Medical Center, East Campus
Davenport, Iowa, 52803
About this study
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
- Being tested
- Organic, Unrefined Coconut Oil, Medline Remedy Phytoplex Z-Guard Skin Protectant
- Medical subject headings
- Dermatitis, Contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organic, Unrefined Coconut OilOther
Medline Remedy Phytoplex Z-Guard Skin ProtectantOther
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Other: Medline Remedy Phytoplex Z-Guard Skin Protectant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Days Free From Diaper Dermatitis
The number of days free from diaper dermatitis.
Measured: Once, at hospital discharge, an average of 2 weeks
The Number of Patients Experiencing Adverse Events
The number of patients experiencing adverse events.
Measured: Once, at hospital discharge, an average of 2 weeks
Secondary outcomes (1)
The Percent of Parents Stating Satisfaction With the Diaper Dermatitis Treatment Used
The percent of parents stating satisfaction with the diaper dermatitis treatment used Measured by a parent satisfaction survey
Measured: Once, at study completion for hospital discharge, an average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2015 (estimated)
- Study startJan 2016
- Primary completion30 Jun 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dermatitis, ContactStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genesis Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02614248
- Sponsor's protocol ID
- 817035
- Status last verified
- Sep 2024
- First submitted
- 16 Nov 2015
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population
- ClinicalTrials.gov ID
- NCT02614248
- Acronym / sponsor ID
- 817035
- Conditions
- Dermatitis, Contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Genesis Health SystemUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 25 Nov 2015 (estimated)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coconut Oil | Experimental | Other: Organic, Unrefined Coconut OilParticipants 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). |
| Standard of Care | Active comparator | Other: Medline Remedy Phytoplex Z-Guard Skin ProtectantParticipants 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). |
Who may qualify
- Ages
- 5 hours to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organic, Unrefined Coconut Oil | Other | Coconut Oil |
| Medline Remedy Phytoplex Z-Guard Skin Protectant | Other | Standard of Care |
Primary outcome
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.
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Organic, Unrefined Coconut Oil and Medline Remedy Phytoplex Z-Guard Skin Protectant in people with Dermatitis, Contact, run by Genesis Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Days Free From Diaper Dermatitis (time frame: Once, at hospital discharge, an average of 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.