Sunflower and Olive Oils for Preventing Diaper Dermatitis in Hospitalized Infants (DD-OIL)

April 1, 2026 updated by: Behlül Okuşluk, Dicle University

The Effect of Sunflower and Olive Oils on Diaper Dermatitis in Hospitalized Infants Treated With Antibiotics: A Quasi-Experimental Study

This quasi-experimental study aimed to evaluate the effects of sunflower oil and olive oil on the development of diaper dermatitis in hospitalized infants receiving antibiotic therapy. Infants aged 0-24 months were assigned to sunflower oil, olive oil, and control groups. Oils were applied to the diaper area after each diaper change. Infants were followed daily for 3-7 days, and diaper dermatitis severity was assessed using a four-stage clinical classification. The incidence of diaper dermatitis was compared between groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diaper dermatitis is a common skin condition in infants and occurs more frequently in hospitalized infants receiving systemic antibiotics. This quasi-experimental study evaluated the preventive effects of sunflower oil and olive oil on diaper dermatitis. The study included 150 infants aged 0-24 months hospitalized and receiving antibiotic therapy. Participants were assigned to three groups: sunflower oil, olive oil, and control. In the intervention groups, oils were applied to the diaper area after each diaper change, while the control group received routine care. Infants were followed daily for 3-7 days, and diaper dermatitis severity was assessed using a four-stage clinical classification. The primary outcome was the incidence of diaper dermatitis. The study aimed to determine whether sunflower oil and olive oil reduce diaper dermatitis in hospitalized infants.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Mardin
      • Midyat, Mardin, Turkey (Türkiye), 47500
        • Midyat State Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infants aged 0-24 months
  • Hospitalized and receiving systemic antibiotic therapy
  • Expected hospital stay of 3-7 days
  • Using disposable diapers
  • Written informed parental consen

Exclusion Criteria:

  • Premature or low birth weight infants
  • Existing diaper dermatitis
  • Diarrhea or oral candidiasis
  • Chronic skin diseases (eczema, atopy, seborrheic dermatitis)
  • Receiving antifungal treatment
  • Neurological or urological anomalies
  • Use of urinary catheter or bag
  • Toilet-trained infants

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sunflower Oil
Participants received sunflower oil applied to the diaper area after each diaper change during hospitalization.
Other: Sunflower Oil
Sunflower oil applied to the diaper area after each diaper change during hospitalization.
Experimental: Olive Oil
Participants received olive oil applied to the diaper area after each diaper change during hospitalization.
Other: Olive Oil
Olive oil applied to the diaper area after each diaper change during hospitalization.
Active Comparator: Control
Participants received routine diaper care without topical oil application.
Other: Routine Care
Routine diaper care without topical oil application during hospitalization.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of diaper dermatitis
Time Frame: During hospitalization (3 days up to 7 days)
Incidence of diaper dermatitis assessed using diaper dermatitis severity scoring system in hospitalized infants receiving sunflower oil, olive oil, or routine care.
During hospitalization (3 days up to 7 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of diaper dermatitis
Time Frame: During hospitalization (3-7 days)
Severity of diaper dermatitis assessed daily using diaper dermatitis severity scoring system in hospitalized infants.
During hospitalization (3-7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dicle University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2024

Primary Completion (Actual)

July 31, 2024

Study Completion (Actual)

July 31, 2024

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 1, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DD-OIL-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be publicly shared due to privacy and ethical restrictions involving infant participants. De-identified data may be available from the corresponding author upon reasonable request.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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