Diaper Dermatitis
Conditions
Keywords
Diaper Dermatitis, Diaper Rash, Breast Milk, Maternal Breast Milk, Barrier Creams, Nurse-Led Intervention
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.
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.
Interventions
BIOLOGICALTopical 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.
DRUGCommercial 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.
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Diaper Dermatitis Severity Scale (DDSS) Score | Baseline (Day 0) to Day 7 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Clinically Meaningful Improvement | 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. |
| Need for Additional Topical Treatment | Day 0 to Day 7 | Requirement for additional topical treatment or escalation of care during the follow-up period due to insufficient clinical improvement. |
Countries
Palestinian Territories
Contacts
CONTACTRasha N Qandeel, RN, PhD Candidate
STUDY_DIRECTORTan W Ling, PhD
Department of Nursing Science, Faculty of Medicine, Universiti Malaya
Outcome results
None listed