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

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

160

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Palæstinensiske territorier
    • Tulkarm
      • Tulkarm, Tulkarm, Palæstinensiske territorier
        • Palestinian Ministry of Health Primary Health Care Clinics
        • Kontakt:
        • Ledende efterforsker:
          • Rasha N Qandeel, RN,MSc, PhD candiate

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Biologisk: 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.
Aktiv komparator: 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
Medicin: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Diaper Dermatitis Severity Scale (DDSS) Score
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time to Clinically Meaningful Improvement
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Malaya

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juni 2026

Primær færdiggørelse (Anslået)

1. december 2026

Studieafslutning (Anslået)

1. december 2026

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UM-NUR-DD-2026-01

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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