Clinical Trial

Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months

Study acronym: NURSE-DD
Not Yet Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-06-02.
Trial Details
NCT Number NCT07633808
Lead Sponsor University of Malaya
Conditions Diaper Dermatitis
Enrollment 160 participants
Start Date 2026-06
Primary Completion 2026-12 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2026-06-11