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

NCT07633808 | Not Yet Recruiting

• 1 other identifier: UM-NUR-DD-2026-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diaper Dermatitis

Keywords

Diaper Dermatitis; Diaper Rash; Breast Milk; Maternal Breast Milk; Barrier Creams; Nurse-Led Intervention

Outcome Measures

Primary Outcomes (1)

• Change in Diaper Dermatitis Severity Scale (DDSS) Score

  Diaper dermatitis severity will be assessed using the Diaper Dermatitis Severity Scale (DDSS), a validated clinical scale ranging from 0 to 6, where higher scores indicate more severe diaper dermatitis and lower scores indicate clinical improvement. Changes in DDSS scores from baseline (Day 0) to Day 7 will be compared between the maternal breast milk group and the commercial barrier cream group.

  Baseline (Day 0) to Day 7

Secondary Outcomes (2)

• Time to Clinically Meaningful Improvement

  Day 0 to Day 7

• Need for Additional Topical Treatment

  Day 0 to Day 7

Study Arms (2)

Maternal Breast Milk

EXPERIMENTAL

Children with mild-to-moderate diaper dermatitis will receive topical maternal breast milk according to the standardized nurse-led management protocol. Caregivers will be instructed on the application procedure, monitoring requirements, and follow-up schedule.

Biological: Topical Maternal Breast Milk

Commercial Barrier Cream

ACTIVE COMPARATOR

Children with mild-to-moderate diaper dermatitis will receive commercially available barrier cream according to routine care procedures and the standardized nurse-led management protocol

Drug: Commercial Barrier Cream

Interventions

Topical Maternal Breast Milk BIOLOGICAL

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.

Maternal Breast Milk

Commercial Barrier Cream DRUG

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.

Commercial Barrier Cream

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

Palestinian Ministry of Health Primary Health Care Clinics

Tulkarm, Tulkarm, Palestinian Territories

Location

Related Publications (1)

• Buckley BS, Mantaring JB, Dofitas RB, Lapitan MC, Monteagudo A. A New Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants: Development and Validation. Pediatr Dermatol. 2016 Nov;33(6):632-639. doi: 10.1111/pde.12988. Epub 2016 Sep 22.

  PMID: 27653955 BACKGROUND

MeSH Terms

Conditions

Diaper Rash

Condition Hierarchy (Ancestors)

Dermatitis, Irritant; Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Tan W Ling, PhD

  Department of Nursing Science, Faculty of Medicine, Universiti Malaya

  STUDY DIRECTOR

Central Study Contacts

Rasha N Qandeel, RN, PhD Candidate

CONTACT

+972598317782; 25069650@siswa.um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessment will be performed by trained assessors who will be blinded to group allocation whenever feasible. Participants and care providers cannot be blinded because of the nature of the interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned in a 1:1 ratio to one of two parallel intervention groups: topical maternal breast milk or commercial barrier creams. Both groups will receive standardized nurse-led assessment, caregiver education, and follow-up according to the study protocol.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-05

Locations

PA (1)