Effect of Using Oxygen on the Diaper Dermatitis in Infants

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05427760

Enrollment

103

Registered

2022-06-22

Start date

2022-10-15

Completion date

2023-04-15

Last updated

2024-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaper Dermatitis, Diaper Rash

Keywords

infant, diaper dermatitis, diaper rash, oxygen

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.

Interventions

DRUGOxygen

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender

ALL

Age

1 Days to 28 Days

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026