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

Diaper dermatitis is one of the most common skin conditions affecting infants and young children during the diaper-wearing period. Despite the availability of several preventive and therapeutic approaches, management practices remain inconsistent, particularly in primary healthcare settings. Commercial barrier creams are commonly recommended; however, accessibility, cost, and variations in caregiver adherence may influence treatment outcomes.

Maternal breast milk has been proposed as a potential topical intervention because of its antimicrobial, anti-inflammatory, and wound-healing properties. Previous studies have suggested beneficial effects in preventing and treating diaper dermatitis; however, evidence remains limited regarding its implementation within structured nurse-led care models and routine primary healthcare services.

The purpose of this study is to evaluate the effectiveness of a nurse-led management protocol using topical maternal breast milk compared with commercial barrier creams for children aged 0-24 months with mild-to-moderate diaper dermatitis.

This study will employ an explanatory sequential mixed-methods design. Phase I will consist of a pragmatic randomized controlled trial conducted in Palestinian primary healthcare clinics. Eligible children will be randomly assigned to receive either topical maternal breast milk or commercially available barrier creams as part of a standardized nurse-led management protocol. The primary outcome will be change in diaper dermatitis severity measured using the Diaper Dermatitis Severity Scale (DDSS) at baseline and Day 7. Secondary outcomes will include time to clinically meaningful improvement, complete resolution of symptoms, and need for additional treatment.

Phase II will involve qualitative descriptive interviews with nurses who participated in implementing the intervention. These interviews will explore experiences, feasibility, barriers, facilitators, and perceptions regarding integration of the intervention into routine clinical practice.

The study aims to generate evidence regarding the clinical effectiveness and practical implementation of maternal breast milk as a low-cost and accessible management option for diaper dermatitis within primary healthcare settings.

Inclusion criteria

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.

Exclusion criteria

• 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.