Diaper dermatitis is a common inflammatory skin condition among children aged 0-24 months. Although commercial barrier creams are widely used, maternal breast milk has been suggested as a safe, accessible, and low-cost alternative due to its antimicrobial and anti-inflammatory properties. However, evidence regarding its effectiveness within structured nurse-led management programs in primary healthcare settings remains limited.
This study aims to compare the effectiveness of topical maternal breast milk and commercial barrier creams in the management of mild-to-moderate diaper dermatitis among children aged 0-24 months attending primary healthcare clinics in Palestine. The study will use a mixed-methods design consisting of a pragmatic randomized controlled trial followed by qualitative interviews with nurses. Clinical outcomes will be assessed using the Diaper Dermatitis Severity Scale (DDSS), and qualitative findings will explore the feasibility and implementation of the nurse-led intervention in routine practice.
None
Severe diaper dermatitis requiring immediate medical treatment. Suspected or confirmed fungal, bacterial, or other secondary skin infection requiring alternative treatment.
Parallel
Topical Maternal Breast Milk
Biological/VaccineFresh maternal breast milk will be applied topically to the affected diaper area after routine diaper changing according to the study protocol. Caregivers will be instructed by trained nurses on the correct method, frequency, and duration of application. Participants will receive standardized nurse-led assessment, caregiver education, and follow-up monitoring throughout the 7-day intervention period.
Commercial Barrier Cream
DrugCommercially available zinc oxide-based barrier cream will be applied topically to the affected diaper area according to the study protocol and routine clinical practice. Caregivers will be instructed by trained nurses on the correct method, frequency, and duration of application. Participants will receive standardized nurse-led assessment, caregiver education, and follow-up monitoring throughout the 7-day intervention period.
Change in Diaper Dermatitis Severity Scale (DDSS) Score
Diaper dermatitis severity will be assessed using the Diaper Dermatitis Severity Scale (DDSS), a validated clinical scale ranging from 0 to 6, where higher scores indicate more severe diaper dermatitis and lower scores indicate clinical improvement. Changes in DDSS scores from baseline (Day 0) to Day 7 will be compared between the maternal breast milk group and the commercial barrier cream group.
Time to Clinically Meaningful Improvement
Time required to achieve clinically meaningful improvement in diaper dermatitis severity based on changes in DDSS scores during the study period.
Need for Additional Topical Treatment
Requirement for additional topical treatment or escalation of care during the follow-up period due to insufficient clinical improvement.
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