Dermatitis, Contact
Conditions
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.
Interventions
OTHEROrganic, Unrefined Coconut Oil
OTHERMedline Remedy Phytoplex Z-Guard Skin Protectant
Sponsors
Genesis Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Hours to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Number of Days Free From Diaper Dermatitis | Once, at hospital discharge, an average of 2 weeks | The number of days free from diaper dermatitis. |
| The Number of Patients Experiencing Adverse Events | Once, at hospital discharge, an average of 2 weeks | The number of patients experiencing adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Percent of Parents Stating Satisfaction With the Diaper Dermatitis Treatment Used | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 75 |
| 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 | 74 |
| Total | 149 |
Baseline characteristics
| Characteristic | Standard of Care | Total | Coconut Oil |
|---|---|---|---|
| Age, Categorical <=18 years | 74 Participants | 149 Participants | 75 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3.0 Days | 3.0 Days | 3.0 Days |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 74 participants | 149 participants | 75 participants |
| Sex: Female, Male Female | 28 Participants | 60 Participants | 32 Participants |
| Sex: Female, Male Male | 46 Participants | 89 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 75 | 0 / 74 |
| other Total, other adverse events | 29 / 75 | 23 / 74 |
| serious Total, serious adverse events | 0 / 75 | 0 / 74 |
Outcome results
Primary
The Number of Days Free From Diaper Dermatitis
The number of days free from diaper dermatitis.
Time frame: Once, at hospital discharge, an average of 2 weeks
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Coconut Oil | The Number of Days Free From Diaper Dermatitis | 4.065 Days | Standard Deviation 0 |
| Standard of Care | The Number of Days Free From Diaper Dermatitis | 4.274 Days | Standard Deviation 0 |
Primary
The Number of Patients Experiencing Adverse Events
The number of patients experiencing adverse events.
Time frame: Once, at hospital discharge, an average of 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coconut Oil | The Number of Patients Experiencing Adverse Events | 29 Participants |
| Standard of Care | The Number of Patients Experiencing Adverse Events | 22 Participants |
Secondary
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
Time frame: Once, at study completion for hospital discharge, an average of 2 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Coconut Oil | The Percent of Parents Stating Satisfaction With the Diaper Dermatitis Treatment Used | 60 Participants |
| Standard of Care | The Percent of Parents Stating Satisfaction With the Diaper Dermatitis Treatment Used | 55 Participants |