Effect Of Using Oxygen On The Diaper Dermatitis In Infants

Diaper Rash Clinical Trial

Official title:

Effect Of Using Oxygen On The Diaper Dermatitis In Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05427760
• Other study ID #: 386964
• Status: Completed
• Phase: N/A
• Start date: October 15, 2022
• Est. completion date: April 15, 2023

Study information

• Verified date: September 2023
• Source: Istanbul University - Cerrahpasa (IUC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: April 15, 2023
• Est. primary completion date: March 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Diaper Dermatitis
• Diaper Rash

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Turkey	Istanbul University Cerrahpasa	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

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* Note: There are 123 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diaper dermatitis healing scale result	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.	72 hours