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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Organic, Unrefined Coconut Oil | Other |
| ||
| Medline Remedy Phytoplex Z-Guard Skin Protectant |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Days Free From Diaper Dermatitis | The number of days free from diaper dermatitis. | Once, at hospital discharge, an average of 2 weeks |
| The Number of Patients Experiencing Adverse Events | The number of patients experiencing adverse events. | Once, at hospital discharge, an average of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Once, at study completion for hospital discharge, an average of 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Genesis Medical Center, East Campus | Davenport | Iowa | 52803 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Days Free From Diaper Dermatitis | The number of days free from diaper dermatitis. | Posted | Median | Standard Deviation | Days | Once, at hospital discharge, an average of 2 weeks |
|
1 month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory syncitial virus infection | Respiratory, thoracic and mediastinal disorders | SNOMED CT | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michelle Martin, RN | Genesis Medical Center | 562-421-7743 | MartinMi@genesishealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 29, 2017 | Dec 7, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 11, 2015 | Mar 14, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003877 | Dermatitis, Contact |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
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| Other |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | Days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Primary | The Number of Patients Experiencing Adverse Events | The number of patients experiencing adverse events. | Posted | Count of Participants | Participants | Once, at hospital discharge, an average of 2 weeks |
|
|
|
| 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 | Posted | Count of Participants | Participants | Once, at study completion for hospital discharge, an average of 2 weeks |
|
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| 29 |
| 75 |
| EG001 | 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 | 0 | 74 | 0 | 74 | 23 | 74 |
| Lingual frenum | General disorders | SNOMED CT | Systematic Assessment |
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| Neonatal hyperbilirubinemia | Hepatobiliary disorders | SNOMED CT | Systematic Assessment |
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| Localized eruption of skin | Skin and subcutaneous tissue disorders | SNOMED CT | Systematic Assessment | Rash on back- not diaper rash |
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| Bleeding skin | Skin and subcutaneous tissue disorders | SNOMED CT | Systematic Assessment | Diaper area bleeding |
|
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