Effect of Using Oxygen on the Diaper Dermatitis in Infants

NCT ID: NCT05427760

Last Updated: 2024-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-15
• Study Completion Date: 2023-04-15

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.

Conditions

Diaper Rash; Diaper Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oxygen Group

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.

Group Type: EXPERIMENTAL

Oxygen

Intervention Type: DRUG

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)

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oxygen

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)

Intervention Type: DRUG

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

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Elif Dogan

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elif Dogan

Role: PRINCIPAL_INVESTIGATOR

Researcher Assistant

Locations

Istanbul University Cerrahpasa

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

386964

Identifier Type: -

Identifier Source: org_study_id