NCT07517003

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 20, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2026

Completed
Last Updated

April 8, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 1, 2026

Last Update Submit

April 1, 2026

Conditions

Diaper Dermatitis

Keywords

InfantSunflower oilOlive oilDiaper rashAntibiotics

Outcome Measures

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.

    During hospitalization (3 days up to 7 days)

Secondary Outcomes (1)

  • Severity of diaper dermatitis

    During hospitalization (3-7 days)

Study Arms (3)

Sunflower Oil

EXPERIMENTAL

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

Other: Sunflower Oil

Olive Oil

EXPERIMENTAL

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

Other: Olive Oil

Control

ACTIVE COMPARATOR

Participants received routine diaper care without topical oil application.

Other: Routine Care

Interventions

Olive OilOTHER

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

Olive Oil
Routine CareOTHER

Routine diaper care without topical oil application during hospitalization.

Control
Sunflower OilOTHER

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

Sunflower Oil

Eligibility Criteria

Age0 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Midyat State Hospital

Midyat, Mardin, 47500, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diaper Rash

Interventions

Sunflower OilOlive Oil

Condition Hierarchy (Ancestors)

Dermatitis, IrritantDermatitis, ContactDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Intervention Hierarchy (Ancestors)

Plant OilsPlant PreparationsBiological ProductsComplex MixturesDietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedOilsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Participants were assigned to three parallel groups: sunflower oil, olive oil, and routine care control. Oils were applied after each diaper change during hospitalization.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

April 1, 2026

First Posted

April 8, 2026

Study Start

January 20, 2024

Primary Completion

July 31, 2024

Study Completion

July 31, 2024

Last Updated

April 8, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)