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.
Who can participate
Age range
0 Months – 12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Severity of diaper dermatitis in infants measured by the Modified Diaper Dermatitis Severity Index (MDDDSI)
Timeframe: Baseline and weekly assessments for 6 weeks during intervention