Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months (NURSE-DD)
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Rasha N Qandeel, RN, PhD Candidate
- Telefonní číslo: +972598317782
- E-mail: 25069650@siswa.um.edu.my
Studijní místa
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Tulkarm
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Tulkarm, Tulkarm, Palestinská území
- Palestinian Ministry of Health Primary Health Care Clinics
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Kontakt:
- Basma R Rajab, MSc
- Telefonní číslo: 00972562401620
- E-mail: Basmarajab40@gmail.com
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Vrchní vyšetřovatel:
- Rasha N Qandeel, RN,MSc, PhD candiate
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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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.
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Aktivní komparátor: 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
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Diaper Dermatitis Severity Scale (DDSS) Score
Časové okno: Baseline (Day 0) to Day 7
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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.
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Baseline (Day 0) to Day 7
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Time to Clinically Meaningful Improvement
Časové okno: Day 0 to Day 7
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Time required to achieve clinically meaningful improvement in diaper dermatitis severity based on changes in DDSS scores during the study period.
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Day 0 to Day 7
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Need for Additional Topical Treatment
Časové okno: Day 0 to Day 7
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Requirement for additional topical treatment or escalation of care during the follow-up period due to insufficient clinical improvement.
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Day 0 to Day 7
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Ředitel studie: Tan W Ling, PhD, Department of Nursing Science, Faculty of Medicine, Universiti Malaya
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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