Trial Outcomes & Findings for The Use of Coconut Oil for the Prevention and Treatment of Diaper Dermatitis in the NICU Population (NCT NCT02614248)
NCT ID: NCT02614248
Last Updated: 2024-10-15
Results Overview
The number of days free from diaper dermatitis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
149 participants
Primary outcome timeframe
Once, at hospital discharge, an average of 2 weeks
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
74
|
|
Overall Study
COMPLETED
|
72
|
70
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Coconut Oil
n=75 Participants
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
|
Standard of Care
n=74 Participants
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
|
Total
n=149 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
75 Participants
n=75 Participants
|
74 Participants
n=74 Participants
|
149 Participants
n=149 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=75 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=149 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=75 Participants
|
0 Participants
n=74 Participants
|
0 Participants
n=149 Participants
|
|
Age, Continuous
|
3.0 Days
n=75 Participants
|
3.0 Days
n=74 Participants
|
3.0 Days
n=149 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=75 Participants
|
28 Participants
n=74 Participants
|
60 Participants
n=149 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=75 Participants
|
46 Participants
n=74 Participants
|
89 Participants
n=149 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
75 participants
n=75 Participants
|
74 participants
n=74 Participants
|
149 participants
n=149 Participants
|
PRIMARY outcome
Timeframe: Once, at hospital discharge, an average of 2 weeksThe number of days free from diaper dermatitis.
Outcome measures
| Measure |
Coconut Oil
n=75 Participants
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
|
Standard of Care
n=74 Participants
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
|
|---|---|---|
|
The Number of Days Free From Diaper Dermatitis
|
4.065 Days
Standard Deviation 0
|
4.274 Days
Standard Deviation 0
|
PRIMARY outcome
Timeframe: Once, at hospital discharge, an average of 2 weeksThe number of patients experiencing adverse events.
Outcome measures
| Measure |
Coconut Oil
n=75 Participants
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
|
Standard of Care
n=74 Participants
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
|
|---|---|---|
|
The Number of Patients Experiencing Adverse Events
|
29 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: Once, at study completion for hospital discharge, an average of 2 weeksThe percent of parents stating satisfaction with the diaper dermatitis treatment used Measured by a parent satisfaction survey
Outcome measures
| Measure |
Coconut Oil
n=66 Participants
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
|
Standard of Care
n=65 Participants
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
|
|---|---|---|
|
The Percent of Parents Stating Satisfaction With the Diaper Dermatitis Treatment Used
|
60 Participants
|
55 Participants
|
Adverse Events
Coconut Oil
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Coconut Oil
n=75 participants at risk
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
|
Standard of Care
n=74 participants at risk
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
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory syncitial virus infection
|
1.3%
1/75 • Number of events 1 • 1 month
|
1.4%
1/74 • Number of events 1 • 1 month
|
|
General disorders
Lingual frenum
|
1.3%
1/75 • Number of events 1 • 1 month
|
1.4%
1/74 • Number of events 1 • 1 month
|
|
Hepatobiliary disorders
Neonatal hyperbilirubinemia
|
8.0%
6/75 • Number of events 6 • 1 month
|
10.8%
8/74 • Number of events 8 • 1 month
|
|
Skin and subcutaneous tissue disorders
Localized eruption of skin
|
1.3%
1/75 • Number of events 1 • 1 month
|
0.00%
0/74 • 1 month
|
|
Skin and subcutaneous tissue disorders
Bleeding skin
|
26.7%
20/75 • Number of events 20 • 1 month
|
17.6%
13/74 • Number of events 13 • 1 month
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place