Sunflower and Olive Oils for Preventing Diaper Dermatitis in Hospitalized Infants

NCT07517003 — Not applicable, Completed, 150 participants, Dicle University

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

RegistryNCT07517003, acronym DD-OIL
StatusCompleted
PhaseNot applicable
Study typeInterventional; non randomized, parallel, masking: none, prevention
Enrollment150 (Actual)
SponsorDicle University (Other)
ConditionsDiaper Dermatitis
InterventionsSunflower Oil, Olive Oil, Routine Care (Other)
Datesstart 2024-01-20, primary completion 2024-07-31, completion 2024-07-31, first posted 2026-04-08, last updated 2026-08-27
Locations1 site in Turkey (Türkiye)

Related Papers Related Patents Related Grants Related Experts
All trials for Diaper Dermatitis All trials of Sunflower Oil All trials of Olive Oil

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Sunflower OilExperimentalOther: Sunflower OilParticipants received sunflower oil applied to the diaper area after each diaper change during hospitalization.
Olive OilExperimentalOther: Olive OilParticipants received olive oil applied to the diaper area after each diaper change during hospitalization.
ControlActive comparatorOther: Routine CareParticipants received routine diaper care without topical oil application.
  • Sunflower Oil (Other): Sunflower oil applied to the diaper area after each diaper change during hospitalization.
  • Olive Oil (Other): Olive oil applied to the diaper area after each diaper change during hospitalization.
  • Routine Care (Other): Routine diaper care without topical oil application during hospitalization.

+Outcome measures

Primary outcomes

  • Incidence of diaper dermatitis [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.

Secondary outcomes

  • Four-grade clinical classification described by Kırçuval (2001) [During hospitalization (3-7 days)]: 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.

+Eligibility

Sex: All, ages: 0 Months to 24 Months

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

+Locations (1)

FacilityCityCountryStatus
Midyat State HospitalMidyat, MardinTurkey (Türkiye)