An interventional study of Topical Maternal Breast Milk and Commercial Barrier Cream in Diaper Dermatitis, sponsored by University of Malaya. Not yet recruiting at 1 site in Palestinian Territories. Open to participants aged Up to 24 Months. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by University of Malaya · Not applicable, Interventional, and Treatment
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.
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.
38 studies on the registry are indexed under Diaper Rash; 4 are open to participants now.
This study's planned enrollment of 160 is above the median of 92 across 28 interventional studies indexed under Diaper Rash.
Browse Diaper Rash studies →University of Malaya is the lead sponsor of 284 studies on the registry; 58 are open to participants now.
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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 provided by the child's parent or legal guardian.
Exclusion Criteria:
Current use of systemic antibiotics or topical medications that may interfere with outcome assessment.
Known or 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
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.
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.
Time frame: Baseline (Day 0) to Day 7
Time to Clinically Meaningful Improvement
Time required to achieve clinically meaningful improvement in diaper dermatitis severity based on changes in DDSS scores during the study period.
Time frame: Day 0 to Day 7
Need for Additional Topical Treatment
Requirement for additional topical treatment or escalation of care during the follow-up period due to insufficient clinical improvement.
Time frame: Day 0 to Day 7
Plan to share: Undecided — 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.
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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