Effect Of Using Oxygen On The Diaper Dermatitis In Infants

Study Overview
=================
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.

Official Title
-----------------
Effect Of Using Oxygen On The Diaper Dermatitis In Infants

Conditions
-----------------
Diaper Rash, Diaper Dermatitis

Intervention / Treatment
-----------------
* Drug: Oxygen


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 28 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxygen Group<br>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. | Drug: Oxygen<br>* 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)<br>|
| No Intervention: Control Group<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant, diaper dermatitis, diaper rash, oxygen