Back to resultsEffect Of Using Oxygen On The Diaper Dermatitis In Infants
Primary Purpose
Diaper Rash, Diaper Dermatitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Diaper Rash focused on measuring infant, diaper dermatitis, diaper rash, oxygen
Eligibility Criteria
Inclusion Criteria:
- Approved by the family for the study
- Born between 34-42. gestational weeks
- No skin disease other than diaper dermatitis
- No skin lesions of another disease other than dermatitis-related lesions in the gland area
- Newborns who has stable vital signs
Exclusion Criteria:
- Having a skin disease other than diaper dermatitis
- Having a lesion on the skin due to another disease
- Having a known skin allergy
- Born before 34. gestational weeks
- Having a gastrointestinal disease
Sites / Locations
- Istanbul University Cerrahpasa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Oxygen Group
Control Group
Arm Description
After the baby's diaper is changed, an oxygen hose placed inside the diaper will provide free oxygen flow to the diaper area. Oxygen will be applied for 1 hour at each diaper change at a flow rate of 5L/min and at a concentration of 21% FiO2 which is equivalent to room air.
This group will only receive routine care: Diaper will be changed using disposable wet wipes and disposable baby diaper. A barrier cream containing 40% zinc oxide will be applied to the cleaned diaper area as a thin layer to cover the skin. Baby's diaper change will be done 8 times a day, every three hours.
Outcomes
Primary Outcome Measures
Diaper dermatitis healing scale result
Expecting to healing diaper dermatitis symptoms at the time of intervention. The scale maximum value: 6 and minimum value: 0. As the scale score increases, the severity of dermatitis increases.
Secondary Outcome Measures
Full Information
NCT ID
NCT05427760
First Posted
June 14, 2022
Last Updated
September 20, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT05427760
Brief Title
Effect Of Using Oxygen On The Diaper Dermatitis In Infants
Official Title
Effect Of Using Oxygen On The Diaper Dermatitis In Infants
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
March 15, 2023 (Actual)
Study Completion Date
April 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
Background: Airing the diaper area has a positive effect on dermatitis. In addition, it is reported in the literature that oxygen is effective in wound care. The aim of our study is to investigate the effect of oxygen on infant diaper dermatitis.
Method: The study population consisted of infants will admit to the neonatal intensive care unit of a public hospital in Istanbul between October 2022 and April 2023. Sixty newborns who met the study criteria will randomly divide into two as the experimental (n=30) and control (n=30) groups. Personal data form and diaper dermatitis observation form will be used to obtain the data. All babies' diapers will be changed 8 times a day. Oxygen flow will be applied to the experimental group for one hour after each diaper change. The degree of diaper dermatitis will be evaluated every 24 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diaper Rash, Diaper Dermatitis
Keywords
infant, diaper dermatitis, diaper rash, oxygen
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
103 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oxygen Group
Arm Type
Experimental
Arm Description
After the baby's diaper is changed, an oxygen hose placed inside the diaper will provide free oxygen flow to the diaper area.
Oxygen will be applied for 1 hour at each diaper change at a flow rate of 5L/min and at a concentration of 21% FiO2 which is equivalent to room air.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will only receive routine care: Diaper will be changed using disposable wet wipes and disposable baby diaper.
A barrier cream containing 40% zinc oxide will be applied to the cleaned diaper area as a thin layer to cover the skin.
Baby's diaper change will be done 8 times a day, every three hours.
Intervention Type
Drug
Intervention Name(s)
Oxygen
Intervention Description
After changing the diaper, free flow oxygen will be provided to the diaper area for 1 hour with an oxygen cannula placed inside the diaper (oxygen flow is %21 Fio2, 5 L/min)
Primary Outcome Measure Information:
Title
Diaper dermatitis healing scale result
Description
Expecting to healing diaper dermatitis symptoms at the time of intervention. The scale maximum value: 6 and minimum value: 0. As the scale score increases, the severity of dermatitis increases.
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Approved by the family for the study
Born between 34-42. gestational weeks
No skin disease other than diaper dermatitis
No skin lesions of another disease other than dermatitis-related lesions in the gland area
Newborns who has stable vital signs
Exclusion Criteria:
Having a skin disease other than diaper dermatitis
Having a lesion on the skin due to another disease
Having a known skin allergy
Born before 34. gestational weeks
Having a gastrointestinal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Dogan
Organizational Affiliation
Researcher Assistant
Official's Role
Principal Investigator
Facility Information:
Facility Name
Istanbul University Cerrahpasa
City
Istanbul
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Effect Of Using Oxygen On The Diaper Dermatitis In Infants
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