Clinical trial NCT05427760: Effect of Using Oxygen on the Diaper Dermatitis in Infants
Official title: Effect of Using Oxygen on the Diaper Dermatitis in Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diaper Rash
Diaper Dermatitis
Keywords: infant
diaper dermatitis
diaper rash
oxygen
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2022-06-22
Enrollment: 103
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Diaper dermatitis healing scale result
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa
Study officials:
affiliation: Researcher Assistant
name: Elif Dogan
role: PRINCIPAL_INVESTIGATOR
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