Nurse-Led Management of Diaper Dermatitis in Children Aged 0-24 Months: A Mixed-Methods Study of Breast Milk Versus Barrier Creams
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Change in Diaper Dermatitis Severity Scale (DDSS) Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- — 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Topical Maternal Breast Milk (Biological)
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
干预措施: Commercial Barrier Cream (Drug)
结局指标
主要结局
Change in Diaper Dermatitis Severity Scale (DDSS) Score
时间窗: 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.
次要结局
未报告次要终点