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Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
Sponsor: University of Malaya
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.
Official title: Nurse-Led Management of Diaper Dermatitis in Children Aged 0-24 Months: A Mixed-Methods Study of Breast Milk Versus Barrier Creams
Key Details
Gender
All
Age Range
Any - 24 Months
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2026-06
Completion Date
2026-12
Last Updated
2026-06-11
Healthy Volunteers
No
Conditions
Interventions
Topical Maternal Breast Milk
Fresh 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
Commercially 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.
Locations (1)
Palestinian Ministry of Health Primary Health Care Clinics
Tulkarm, Tulkarm, Palestinian Territories