Diaper DermatitisNURSE-DDNCT07633808
Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
A study testing Topical Maternal Breast Milk and Commercial Barrier Cream in people with Diaper Dermatitis, run by University of Malaya at 1 site in Palestinian Territories.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Diaper Dermatitis
- What is being tested?
- Topical Maternal Breast Milk and Commercial Barrier Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 sitePalestinian Territories
- Study dates
- Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Palestinian Territories1 site
Palestinian Ministry of Health Primary Health Care Clinics
Tulkarm, Tulkarm
Basma R Rajab, MSc, 00972562401620, Basmarajab40@gmail.com
Rasha N Qandeel, RN,MSc, PhD candiate
About this study
Official title: 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.
Read the 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.
- Conditions
- Diaper Dermatitis
- Being tested
- Topical Maternal Breast Milk, Commercial Barrier Cream
- Keywords
- Diaper Dermatitis, Diaper Rash, Breast Milk, Maternal Breast Milk, Barrier Creams, Nurse-Led Intervention
- Medical subject headings
- Diaper Rash
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical Maternal Breast MilkBiological
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.
Commercial Barrier CreamDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Maternal Breast Milk | Experimental | 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. Receives: Biological: Topical Maternal Breast Milk |
| Commercial Barrier Cream | Active comparator | 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 Receives: Drug: Commercial Barrier Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 0) to Day 7
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day 0 to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diaper DermatitisStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tan W Ling, PhD, Study director, Department of Nursing Science, Faculty of Medicine, Universiti Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07633808
- Sponsor's protocol ID
- UM-NUR-DD-2026-01
- Acronym
- NURSE-DD
- Status last verified
- May 2026
- First submitted
- 2 Jun 2026
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Buckley BS, Mantaring JB, Dofitas RB, Lapitan MC, Monteagudo A. A New Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants: Development and Validation. Pediatr Dermatol. 2016 Nov;33(6):632-639. doi: 10.1111/pde.12988. Epub 2016 Sep 22.
PubMed 27653955
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse-Led Management of Diaper Dermatitis in Children Aged 0-24 Months: A Mixed-Methods Study of Breast Milk Versus Barrier Creams
- ClinicalTrials.gov ID
- NCT07633808
- Acronym / sponsor ID
- NURSE-DD / UM-NUR-DD-2026-01
- Conditions
- Diaper Dermatitis
- Keywords
- Diaper Dermatitis, Diaper Rash, Breast Milk, Maternal Breast Milk, Barrier Creams, Nurse-Led Intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Maternal Breast Milk | Experimental | Biological: Topical Maternal Breast MilkChildren 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. |
| Commercial Barrier Cream | Active comparator | Drug: Commercial Barrier CreamChildren with mild-to-moderate diaper dermatitis will receive commercially available barrier cream according to routine care procedures and the standardized nurse-led management protocol |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical Maternal Breast MilkFresh 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. | Biological | Maternal Breast Milk |
| Commercial Barrier CreamCommercially 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. | Drug | Commercial Barrier Cream |
Primary outcome
Change in Diaper Dermatitis Severity Scale (DDSS) Score
Time frame: 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.
2 secondary outcomes
Time to Clinically Meaningful Improvement
Time frame: Day 0 to Day 7
Need for Additional Topical Treatment
Time frame: Day 0 to Day 7
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Background: PubMed 27653955Buckley BS, Mantaring JB, Dofitas RB, Lapitan MC, Monteagudo A. A New Scale for Assessing the Severity of Uncomplicated Diaper Dermatitis in Infants: Development and Validation. Pediatr Dermatol. 2016 Nov;33(6):632-639. doi: 10.1111/pde.12988. Epub 2016 Sep 22.
- Individual participant dataSharing planned: 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.
Related trials for Diaper Dermatitis
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Recruiting
Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
Recruiting
Probiotics for Diaper Dermatitis
Diaper Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tan W Ling, PhD study director
Department of Nursing Science, Faculty of Medicine, Universiti Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Topical Maternal Breast Milk and Commercial Barrier Cream in people with Diaper Dermatitis, run by University of Malaya at 1 site in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rasha N Qandeel, RN, PhD Candidate (+972598317782, 25069650@siswa.um.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diaper Dermatitis Severity Scale (DDSS) Score (time frame: Baseline (Day 0) to Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07633808, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.