Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months (NURSE-DD)

June 2, 2026 updated by: University of Malaya

NURSE-LED MANAGEMENT OF DIAPER DERMATITIS IN CHILDREN AGED 0-24 MONTHS: A MIXED-METHODS STUDY OF BREAST MILK VERSUS BARRIER CREAMS

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Palestinian Territories
    • Tulkarm
      • Tulkarm, Tulkarm, Palestinian Territories
        • Palestinian Ministry of Health Primary Health Care Clinics
        • Contact:
        • Principal Investigator:
          • Rasha N Qandeel, RN,MSc, PhD candiate

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maternal Breast Milk
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
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.
Active Comparator: Commercial Barrier Cream
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Diaper Dermatitis Severity Scale (DDSS) Score
Time Frame: Baseline (Day 0) to Day 7
Diaper dermatitis severity will be assessed using the Diaper Dermatitis Severity Scale (DDSS). Changes in DDSS scores from baseline 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Clinically Meaningful Improvement
Time Frame: Day 0 to Day 7
Time required to achieve clinically meaningful improvement in diaper dermatitis severity based on changes in DDSS scores during the study period.
Day 0 to Day 7
Need for Additional Topical Treatment
Time Frame: Day 0 to Day 7
Requirement for additional topical treatment or escalation of care during the follow-up period due to insufficient clinical improvement.
Day 0 to Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Study Director: Tan W Ling, PhD, Department of Nursing Science, Faculty of Medicine, Universiti Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 8, 2026

Study Record Updates

Last Update Posted (Actual)

June 8, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UM-NUR-DD-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The decision regarding sharing individual participant data has not yet been finalized. Any future data sharing will be considered after study completion, publication of the primary results, and in accordance with ethical approval requirements, participant confidentiality protections, and institutional policies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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