Effect Of Using Oxygen On The Diaper Dermatitis In Infants

Sponsor

Istanbul University-Cerrahpasa (Other)

Overall Status

Recruiting

CT.gov ID

NCT05427760

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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 May 2022 and September 2022. Sixty newborns who met the study criteria will randomize and 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.

Condition or Disease	Intervention/Treatment	Phase
Diaper Rash Diaper Dermatitis	Drug: Oxygen	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Treatment

Official Title:

Effect Of Using Oxygen On The Diaper Dermatitis In Infants

Actual Study Start Date :

Jun 15, 2022

Anticipated Primary Completion Date :

Dec 15, 2022

Anticipated Study Completion Date :

Jan 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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)
No Intervention: 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.

Arm

Intervention/Treatment

Experimental: 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.

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)

No Intervention: 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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 28 Days

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University Cerrahpasa	Istanbul		Turkey

Sponsors and Collaborators

Istanbul University-Cerrahpasa

Investigators

Principal Investigator: Elif Dogan, Researcher Assistant

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Elif Dogan, Principal Investigator, Istanbul University-Cerrahpasa

ClinicalTrials.gov Identifier:

NCT05427760

Other Study ID Numbers:

386964

First Posted:

Jun 22, 2022

Last Update Posted:

Jul 1, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Elif Dogan, Principal Investigator, Istanbul University-Cerrahpasa

Additional relevant MeSH terms:

Dermatitis

Diaper Rash

Study Results

No Results Posted as of Jul 1, 2022