Family-centered CareDiaper DermatiNCT07268352
The Effect of Ventilation Frequency on Diaper Dermatitis Recovery and Maternal Self-Efficacy in Infants Aged 0-3 Months: A Randomized Controlled Trial
A study testing Diaper-Free Air Exposure Protocol" in people with Family-centered Care, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Brief Summary Title: The Effect of Ventilation Frequency on Diaper Dermatitis Recovery and Maternal Self-Efficacy in Infants Aged 0-3 Months: A Randomized Controlled Trial Authors: Fatma Şule Bilgiç, Aysu Yıldız Karaahmet, Shahla Shafaati Laleh Background: Diaper dermatitis (DD) is a prevalent condition affecting… Read more about this study
- Who is it for?
- Ages 0 to 12 months
- Conditions the study is for
- Family-centered Care
- What is being tested?
- Diaper-Free Air Exposure Protocol"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Jan 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 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged from 0 months (newborn) to 12 months.
- Infants must exhibit mild to moderate diaper dermatitis as assessed by the Modified Diaper Dermatitis Severity Index (MDDSI) at baseline.
- Written informed consent must be obtained from the parent or legal guardian prior to participation in the study.
- Infants must be in overall good health, without any significant medical conditions that would interfere with the study or require additional treatment for skin conditions.
Who cannot join
- Infants with severe diaper dermatitis or other dermatological conditions affecting the diaper area (e.g., fungal infections, bacterial infections, or other rashes) will be excluded.
- Infants who have received topical treatments (e.g., antifungals, corticosteroids) for diaper dermatitis or other skin conditions within the past 2 weeks prior to enrollment.
- Infants with significant health issues, such as immunosuppression, chronic skin conditions, or other comorbidities that may affect the skin's integrity.
- Infants currently enrolled in other clinical trials or studies that may influence the outcomes of this study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Biruni University
Zeytinburnu, None Selected, 34445
About this study
Brief Summary Title: The Effect of Ventilation Frequency on Diaper Dermatitis Recovery and Maternal Self-Efficacy in Infants Aged 0-3 Months: A Randomized Controlled Trial
Authors: Fatma Şule Bilgiç, Aysu Yıldız Karaahmet, Shahla Shafaati Laleh
Read more
Background: Diaper dermatitis (DD) is a prevalent condition affecting infants aged 0-3 months, causing discomfort for both infants and parents. While traditional management focuses on skin protection, the role of ventilation in recovery is not well-studied. This trial investigates the impact of different ventilation frequencies on diaper dermatitis healing and maternal self-efficacy.
Methods: A randomized controlled trial included 130 infants with mild diaper dermatitis, divided into two groups: Group A (5 minutes of diaper-free air exposure 6 times a day) and Group B (5 minutes of exposure 12 times a day). Recovery was assessed using the Uncomplicated Diaper Dermatitis Severity Rating Scale (UDDSRSI) and maternal self-efficacy was measured with the Perceived Maternal Self-Efficacy Scale (PMSS).
Keywords: Diaper dermatitis, ventilation, maternal self-efficacy, infant care, randomized controlled trial.
Read the detailed description
Detailed Description Title: The Effect of Ventilation Frequency on Diaper Dermatitis Recovery and Maternal Self-Efficacy in Infants Aged 0-3 Months: A Randomized Controlled Trial Background: Diaper dermatitis (DD) is a prevalent skin condition in infants, particularly affecting those aged 0-3 months. It is characterized by inflammation, redness, and irritation in the diaper area, which can lead to significant discomfort for the infant and distress for the caregivers. Traditional management strategies focus on skin protection through frequent diaper changes, proper hygiene practices, and the use of barrier creams. However, the potential benefits of increased ventilation in the diaper area have not been sufficiently explored. This study aims to evaluate how varying frequencies of diaper-free air exposure can influence the recovery of diaper dermatitis and the perceived self-efficacy of mothers caring for affected infants.
Methods: A randomized controlled trial was conducted at a private hospital's Pediatric Outpatient Clinic over a year, from January 2023 to January 2024. A total of 130 infants diagnosed with mild diaper dermatitis were recruited and randomly assigned to two intervention groups:
Group A: Received 5 minutes of diaper-free air exposure 6 times a day. Group B: Received 5 minutes of diaper-free air exposure 12 times a day.
Data were collected at baseline and upon resolution of diaper dermatitis using:
Uncomplicated Diaper Dermatitis Severity Rating Scale (UDDSRSI): This scale assesses the severity of diaper dermatitis based on criteria such as erythema, papules, and skin breakdown.
Perceived Maternal Self-Efficacy Scale (PMSS): This scale evaluates mothers' confidence in their caregiving abilities.
Data Collection Process: The study involved a comprehensive data collection process, including a detailed questionnaire about sociodemographic characteristics and infant health status. Mothers were trained on proper diaper cleaning techniques and the importance of ventilation in managing diaper dermatitis through a structured educational session.
Keywords: Diaper dermatitis, ventilation, maternal self-efficacy, infant care, randomized controlled trial.
- Conditions
- Family-centered Care
- Being tested
- Diaper-Free Air Exposure Protocol"
- Keywords
- Diaper dermatitis, ventilation, maternal self-efficacy, infant care, randomized controlled trial.
- Medical subject headings
- Diaper Rash, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diaper-Free Air Exposure Protocol"Behavioural
The Diaper-Free Air Exposure Protocol is designed to promote the healing of mild diaper dermatitis in infants through structured periods of diaper-free time. This intervention consists of allowing infants to be without a diaper for specific durations throughout the day, aiming to enhance airflow to the affected area and reduce moisture accumulation, which can exacerbate skin irritation.
Duration and Frequency: Infants will be exposed to diaper-free intervals lasting 5 minutes each. The intervention will be implemented with varying frequencies based on the study group: 6 times daily for Group A and 12 times daily for Group B.
Environment: The diaper-free periods will take place in a safe and comfortable environment, ensuring that the infants are not exposed to potential hazards (e.g., cold surfaces, unsanitary conditions). Caregivers will be instructed to monitor the infants during these periods to ensure their safety and comfort.
| Study group | Role | What they receive |
|---|---|---|
| Group A: "Diaper-Free Ventilation: 5 Minutes, 6 Times Daily | Active comparator | This arm of the study focuses on providing infants with diaper-free air exposure as a method to improve recovery from diaper dermatitis. In this group, participants are given the opportunity to be without a diaper for a duration of 5 minutes, and this process is repeated six times throughout the day. Receives: Behavioral: Diaper-Free Air Exposure Protocol" |
| Group B: "Diaper-Free Ventilation: 5 Minutes, 12 Times Daily" | Active comparator | This arm of the study focuses on a more frequent approach to providing infants with diaper-free air exposure as a method to facilitate healing from diaper dermatitis. In this group, participants experience diaper-free intervals for a duration of 5 minutes, repeated twelve times throughout the day. Receives: Behavioral: Diaper-Free Air Exposure Protocol" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of diaper dermatitis in infants measured by the Modified Diaper Dermatitis Severity Index (MDDDSI)
Skin assessments conducted at baseline and weekly using MDDDSI.
Scoring criteria: erythema, edema, erosion, papules, exudate.
Each item scored 0-3; higher scores indicate more severe dermatitis.
Total score used to determine overall severity.
Measured: Baseline and weekly assessments for 6 weeks during intervention
Secondary outcomes (1)
Maternal self-efficacy measured by the Perceived Maternal Self-Efficacy Scale (PMSS)
Baseline and at dermatitis recovery (average 1-3 days after intervention)
Measured: Maternal self-efficacy will be assessed using the Perceived Maternal Self-Efficacy Scale (PMSS), a validated 20-item 4-point Likert scale (range: 20-80). Higher scores indicate greater perceived maternal self-efficacy. The scale will be administered at b
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Jan 2023
- Primary completion29 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Family-centered CareStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahla Shafaati Laleh, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07268352
- Sponsor's protocol ID
- SSL&AYK
- Acronym
- Diaper Dermati
- Status last verified
- Nov 2025
- First submitted
- 16 Nov 2025
- Last updated
- 5 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bilgic FS, Karaahmet AY, Laleh SS. The effect of open to air frequency on diaper dermatitis recovery and maternal self-efficacy in infants aged 0-3 months: a randomized controlled trial. BMC Pediatr. 2026 May 27;26(1):685. doi: 10.1186/s12887-026-06917-0.
PubMed 42204660
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ventilation Frequency on Diaper Dermatitis Recovery and Maternal Self-Efficacy in Infants Aged 0-3 Months: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07268352
- Acronym / sponsor ID
- Diaper Dermati / SSL&AYK
- Conditions
- Family-centered Care
- Keywords
- Diaper dermatitis, ventilation, maternal self-efficacy, infant care, randomized controlled trial.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 29 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 5 Dec 2025 (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.
Brief Summary Title: The Effect of Ventilation Frequency on Diaper Dermatitis Recovery and Maternal Self-Efficacy in Infants Aged 0-3 Months: A Randomized Controlled Trial
Authors: Fatma Şule Bilgiç, Aysu Yıldız Karaahmet, Shahla Shafaati Laleh
Background: Diaper dermatitis (DD) is a prevalent condition affecting infants aged 0-3 months, causing discomfort for both infants and parents. While traditional management focuses on skin protection, the role of ventilation in recovery is not well-studied. This trial investigates the impact of different ventilation frequencies on diaper dermatitis healing and maternal self-efficacy.
Methods: A randomized controlled trial included 130 infants with mild diaper dermatitis, divided into two groups: Group A (5 minutes of diaper-free air exposure 6 times a day) and Group B (5 minutes of exposure 12 times a day). Recovery was assessed using the Uncomplicated Diaper Dermatitis Severity Rating Scale (UDDSRSI) and maternal self-efficacy was measured with the Perceived Maternal Self-Efficacy Scale (PMSS).
Keywords: Diaper dermatitis, ventilation, maternal self-efficacy, infant care, randomized controlled trial.
Detailed description
Detailed Description Title: The Effect of Ventilation Frequency on Diaper Dermatitis Recovery and Maternal Self-Efficacy in Infants Aged 0-3 Months: A Randomized Controlled Trial Background: Diaper dermatitis (DD) is a prevalent skin condition in infants, particularly affecting those aged 0-3 months. It is characterized by inflammation, redness, and irritation in the diaper area, which can lead to significant discomfort for the infant and distress for the caregivers. Traditional management strategies focus on skin protection through frequent diaper changes, proper hygiene practices, and the use of barrier creams. However, the potential benefits of increased ventilation in the diaper area have not been sufficiently explored. This study aims to evaluate how varying frequencies of diaper-free air exposure can influence the recovery of diaper dermatitis and the perceived self-efficacy of mothers caring for affected infants.
Methods: A randomized controlled trial was conducted at a private hospital's Pediatric Outpatient Clinic over a year, from January 2023 to January 2024. A total of 130 infants diagnosed with mild diaper dermatitis were recruited and randomly assigned to two intervention groups:
Group A: Received 5 minutes of diaper-free air exposure 6 times a day. Group B: Received 5 minutes of diaper-free air exposure 12 times a day.
Data were collected at baseline and upon resolution of diaper dermatitis using:
Uncomplicated Diaper Dermatitis Severity Rating Scale (UDDSRSI): This scale assesses the severity of diaper dermatitis based on criteria such as erythema, papules, and skin breakdown.
Perceived Maternal Self-Efficacy Scale (PMSS): This scale evaluates mothers' confidence in their caregiving abilities.
Data Collection Process: The study involved a comprehensive data collection process, including a detailed questionnaire about sociodemographic characteristics and infant health status. Mothers were trained on proper diaper cleaning techniques and the importance of ventilation in managing diaper dermatitis through a structured educational session.
Keywords: Diaper dermatitis, ventilation, maternal self-efficacy, infant care, randomized controlled trial.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: "Diaper-Free Ventilation: 5 Minutes, 6 Times Daily | Active comparator | Behavioral: Diaper-Free Air Exposure Protocol"This arm of the study focuses on providing infants with diaper-free air exposure as a method to improve recovery from diaper dermatitis. In this group, participants are given the opportunity to be without a diaper for a duration of 5 minutes, and this process is repeated six times throughout the day. |
| Group B: "Diaper-Free Ventilation: 5 Minutes, 12 Times Daily" | Active comparator | Behavioral: Diaper-Free Air Exposure Protocol"This arm of the study focuses on a more frequent approach to providing infants with diaper-free air exposure as a method to facilitate healing from diaper dermatitis. In this group, participants experience diaper-free intervals for a duration of 5 minutes, repeated twelve times throughout the day. |
Who may qualify
- Ages
- 0 to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants aged from 0 months (newborn) to 12 months.
- Infants must exhibit mild to moderate diaper dermatitis as assessed by the Modified Diaper Dermatitis Severity Index (MDDSI) at baseline.
- Written informed consent must be obtained from the parent or legal guardian prior to participation in the study.
- Infants must be in overall good health, without any significant medical conditions that would interfere with the study or require additional treatment for skin conditions.
Key exclusion criteria (4 listed)
- Infants with severe diaper dermatitis or other dermatological conditions affecting the diaper area (e.g., fungal infections, bacterial infections, or other rashes) will be excluded.
- Infants who have received topical treatments (e.g., antifungals, corticosteroids) for diaper dermatitis or other skin conditions within the past 2 weeks prior to enrollment.
- Infants with significant health issues, such as immunosuppression, chronic skin conditions, or other comorbidities that may affect the skin's integrity.
- Infants currently enrolled in other clinical trials or studies that may influence the outcomes of this study.
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 |
|---|---|---|
| Diaper-Free Air Exposure Protocol"The Diaper-Free Air Exposure Protocol is designed to promote the healing of mild diaper dermatitis in infants through structured periods of diaper-free time. This intervention consists of allowing infants to be without a diaper for specific durations throughout the day, aiming to enhance airflow to the affected area and reduce moisture accumulation, which can exacerbate skin irritation. Duration and Frequency: Infants will be exposed to diaper-free intervals lasting 5 minutes each. The intervention will be implemented with varying frequencies based on the study group: 6 times daily for Group A and 12 times daily for Group B. Environment: The diaper-free periods will take place in a safe and comfortable environment, ensuring that the infants are not exposed to potential hazards (e.g., cold surfaces, unsanitary conditions). Caregivers will be instructed to monitor the infants during these periods to ensure their safety and comfort. | Behavioural | Group A: "Diaper-Free Ventilation: 5 Minutes, 6 Times Daily, Group B: "Diaper-Free Ventilation: 5 Minutes, 12 Times Daily" |
Primary outcome
Severity of diaper dermatitis in infants measured by the Modified Diaper Dermatitis Severity Index (MDDDSI)
Time frame: Baseline and weekly assessments for 6 weeks during intervention
Skin assessments conducted at baseline and weekly using MDDDSI. Scoring criteria: erythema, edema, erosion, papules, exudate. Each item scored 0-3; higher scores indicate more severe dermatitis. Total score used to determine overall severity.
1 secondary outcome
Maternal self-efficacy measured by the Perceived Maternal Self-Efficacy Scale (PMSS)
Time frame: Maternal self-efficacy will be assessed using the Perceived Maternal Self-Efficacy Scale (PMSS), a validated 20-item 4-point Likert scale (range: 20-80). Higher scores indicate greater perceived maternal self-efficacy. The scale will be administered at b
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 5 Dec 2025.
- Derived from this study: PubMed 42204660Bilgic FS, Karaahmet AY, Laleh SS. The effect of open to air frequency on diaper dermatitis recovery and maternal self-efficacy in infants aged 0-3 months: a randomized controlled trial. BMC Pediatr. 2026 May 27;26(1):685. doi: 10.1186/s12887-026-06917-0.
- Individual participant dataSharing planned: No
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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 Diaper-Free Air Exposure Protocol" in people with Family-centered Care, run by Istanbul University - Cerrahpasa 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 4 inclusion and 4 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 5 Dec 2025. 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?
Severity of diaper dermatitis in infants measured by the Modified Diaper Dermatitis Severity Index (MDDDSI) (time frame: Baseline and weekly assessments for 6 weeks during intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07268352, which also lists 1 linked publication.
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 5 Dec 2025.