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CompletedNCT07517003DD-OILUpdated Aug 27, 2026

Sunflower and Olive Oils for Preventing Diaper Dermatitis in Hospitalized Infants

An interventional study of Sunflower Oil and Olive Oil in Diaper Dermatitis, sponsored by Dicle University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 0 Months to 24 Months. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Dicle University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 2 months after the study started (first participant enrolled Jan 2024, registered Apr 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
0 Months to 24 Months
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Diaper Dermatitis

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Keywords

  • Infant
  • Sunflower oil
  • Olive oil
  • Diaper rash
  • Antibiotics
03

In context

Diaper Rash

38 studies on the registry are indexed under Diaper Rash; 4 are open to participants now.

This study's enrollment of 150 is above the median of 92 across 28 interventional studies indexed under Diaper Rash.

Browse Diaper Rash studies →

Lead sponsor

Dicle University is the lead sponsor of 28 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Months to 24 Months
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    Sunflower Oil

    Participants received sunflower oil applied to the diaper area after each diaper change during hospitalization.

    Other: Sunflower Oil

  • Experimental
    Olive Oil

    Participants received olive oil applied to the diaper area after each diaper change during hospitalization.

    Other: Olive Oil

  • Active comparator
    Control

    Participants received routine diaper care without topical oil application.

    Other: Routine Care

Interventions

  • OtherSunflower Oil

    Sunflower oil applied to the diaper area after each diaper change during hospitalization.

  • OtherOlive Oil

    Olive oil applied to the diaper area after each diaper change during hospitalization.

  • OtherRoutine Care

    Routine diaper care without topical oil application during hospitalization.

06

What researchers measure

Primary outcomes

  1. Incidence of diaper dermatitis

    Incidence of diaper dermatitis assessed using diaper dermatitis severity scoring system in hospitalized infants receiving sunflower oil, olive oil, or routine care.

    Time frame: During hospitalization (3 days up to 7 days)

Secondary outcomes

  1. Four-grade clinical classification described by Kırçuval (2001)

    Diaper dermatitis severity was assessed daily using the four-grade clinical classification described by Kırçuval (2001). Severity ranges from Grade I to Grade IV (1-4). Grade I indicates mild erythema limited to the diaper area; Grade II indicates marked erythema with lesions or desquamation limited to the diaper area; Grade III indicates marked erythema extending to the inner thighs and abdomen; and Grade IV indicates severe erythema with erosion and pustules. Higher grades indicate greater diaper dermatitis severity and therefore a worse outcome.

    Time frame: During hospitalization (3-7 days)

07

Study locations

1 site
  • Midyat State Hospital
    Midyat, Mardin 47500, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 27, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07517003
Lead sponsor
Dicle University
Responsible party
Behlül Okuşluk (Principal Investigator, Ataturk University) — Principal investigator
First posted
Apr 8, 2026
Start date
Jan 20, 2024
Primary completion
Jul 31, 2024
Completion
Jul 31, 2024
Last update
Aug 27, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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