Effect of Using Oxygen on the Diaper Dermatitis in Infants

Istanbul University - Cerrahpasa (IUC)

Status: Completed

Conditions: Diaper Rash; Diaper Dermatitis

Treatments: Drug: Oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT05427760

386964

Details and patient eligibility

About

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.

Enrollment: 103 patients

Sex: All

Ages: 1 to 28 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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103 participants in 2 patient groups

Oxygen Group

Experimental group

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.

Treatment:

Drug: Oxygen

Control Group

No Intervention group

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.