drugset / Trial / NCT07633808

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

NCT07633808

Not yet recruiting 160 enrolled University of Malaya
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2026-06
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Maternal Breast Milk Unknown Topical
Comparator Zinc Oxide Unknown Topical

Indications