Diaper DermatitisDD-OILNCT07517003
Sunflower and Olive Oils for Preventing Diaper Dermatitis in Hospitalized Infants
A study testing Sunflower Oil, Olive Oil and Routine Care in people with Diaper Dermatitis, run by Dicle University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 24 months
- Conditions the study is for
- Diaper Dermatitis
- What is being tested?
- Sunflower Oil, Olive Oil and Routine Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2024to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Diaper Dermatitis
- Being tested
- Sunflower Oil, Olive Oil, Routine Care
- Keywords
- Infant, Sunflower oil, Olive oil, Diaper rash, Antibiotics
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sunflower OilOther
Sunflower oil applied to the diaper area after each diaper change during hospitalization.
Olive OilOther
Olive oil applied to the diaper area after each diaper change during hospitalization.
Routine CareOther
Routine diaper care without topical oil application during hospitalization.
| Study group | Role | What they receive |
|---|---|---|
| Sunflower Oil | Experimental | Participants received sunflower oil applied to the diaper area after each diaper change during hospitalization. Receives: Other: Sunflower Oil |
| Olive Oil | Experimental | Participants received olive oil applied to the diaper area after each diaper change during hospitalization. Receives: Other: Olive Oil |
| Control | Active comparator | Participants received routine diaper care without topical oil application. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During hospitalization (3-7 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start20 Jan 2024
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diaper DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to three parallel groups: sunflower oil, olive oil, and routine care control. Oils were applied after each diaper change during hospitalization.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dicle University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Behlül Okuşluk, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517003
- Sponsor's protocol ID
- DD-OIL-2024
- Acronym
- DD-OIL
- Status last verified
- Aug 2026
- First submitted
- 1 Apr 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sunflower and Olive Oils on Diaper Dermatitis in Hospitalized Infants Treated With Antibiotics: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07517003
- Acronym / sponsor ID
- DD-OIL / DD-OIL-2024
- Conditions
- Diaper Dermatitis
- Keywords
- Infant, Sunflower oil, Olive oil, Diaper rash, Antibiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Dicle UniversityUniversity, hospital or other
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants were assigned to three parallel groups: sunflower oil, olive oil, and routine care control. Oils were applied after each diaper change during hospitalization.
| Arm | Type | Receives |
|---|---|---|
| Sunflower Oil | Experimental | Other: Sunflower OilParticipants received sunflower oil applied to the diaper area after each diaper change during hospitalization. |
| Olive Oil | Experimental | Other: Olive OilParticipants received olive oil applied to the diaper area after each diaper change during hospitalization. |
| Control | Active comparator | Other: Routine CareParticipants received routine diaper care without topical oil application. |
Who may qualify
- Ages
- 0 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- Premature or low birth weight infants
- Existing diaper dermatitis
- Diarrhea or oral candidiasis
- Chronic skin diseases (eczema, atopy, seborrheic dermatitis)
- Receiving antifungal treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sunflower OilSunflower oil applied to the diaper area after each diaper change during hospitalization. | Other | Sunflower Oil |
| Olive OilOlive oil applied to the diaper area after each diaper change during hospitalization. | Other | Olive Oil |
| Routine CareRoutine diaper care without topical oil application during hospitalization. | Other | Control |
Primary outcome
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.
1 secondary outcome
Four-grade clinical classification described by Kırçuval (2001)
Time frame: During hospitalization (3-7 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunflower Oil, Olive Oil and Routine Care in people with Diaper Dermatitis, run by Dicle University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of diaper dermatitis (time frame: During hospitalization (3 days up to 7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.