Effect of Using Oxygen on the Diaper Dermatitis in Infants

Not Applicable

Completed

• Conditions: Diaper Dermatitis; Diaper Rash
• Interventions: Drug: Oxygen

• Registration Number: NCT05427760
• Lead Sponsor: Istanbul University - Cerrahpasa (IUC)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Study Start: 2022-10-15
• Primary Completion: 2023-03-15
• Study Completion: 2023-04-15
• Status Verified: 2023-09
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxygen Group	Oxygen	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.

Primary Outcome Measures

Name	Time	Method
Diaper dermatitis healing scale result	72 hours	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.

Trial Locations

Locations (1)

Istanbul University Cerrahpasa; 🇹🇷 Istanbul, Turkey