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

Starting soon · Not applicable

Conditions studied: Diaper Dermatitis

In brief

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.

Key facts

Study ID

NCT07633808

Run by

University of Malaya

People needed

160

Starts

2026-06-01

Expected to finish

2026-12-01

Last updated by the study team

2026-06-11

Who can join

Age: any, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 0 to 24 months. Diagnosis of mild-to-moderate diaper dermatitis based on clinical assessment. Caregiver willing and able to comply with study procedures and follow-up requirements.
• Availability of maternal breast milk for participants allocated to the maternal breast milk group.
• Written informed consent provided by the child's parent or legal guardian.

You may not qualify if…

• Severe diaper dermatitis requiring immediate medical treatment. Suspected or confirmed fungal, bacterial, or other secondary skin infection requiring alternative treatment.
• Current use of systemic antibiotics or topical medications that may interfere with outcome assessment.
• Known hypersensitivity or contraindication to barrier cream products used in the study.
• Presence of significant dermatological or medical conditions that may affect skin healing or study outcomes.
• Participation in another clinical study during the study period.

Where it is running

• Palestinian Ministry of Health Primary Health Care Clinics — Tulkarm, Tulkarm, Palestinian Territories

Full record on ClinicalTrials.gov

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