Napkin DermatosisNCT07206771
Knowledge, Attitudes, and Practices Among Parents of Children With Napkin Dermatosis and Its Patterns in Assiut University Hospitals.
An observational study of Napkin Dermatosis, run by Assiut University.
Trial summary
Evaluate the level of knowledge , attitude and practices among parents of children with napkin dermatosis and assess the pattern of napkin dermatosis among children up to 2 years old attending Assiut University Hospital (AUH). Read more about this study
- Who is it for?
- Ages 1 day to 24 months
- Conditions the study is for
- Napkin Dermatosis
- How many people
- 240 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 30 Dec 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- 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 1 day to 24 months
- All sexes
- No healthy volunteers
- Child
Study population: Children aged 0-24 months presenting with napkin dermatosis at Assiut University Hospitals outpatient dermatology and pediatric clinics
Who may be able to join
- Children aged up to 2 years attending Assuit University Chlidren's Hospital and dermatology outpatient clinics in AUH during the study period , presenting with skin changes in the diaper area.
- Children whose parents and caregivers provide informed consent for participation.
Who cannot join
- parents and caregivers who refuse or are unable to give informed consent.
- Infants on admission , severely ill or immunocompromised
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Knowledge, Attitudes, and Practices Among Parents of Children With Napkin Dermatosis and Its Patterns in Assiut University Hospitals
Evaluate the level of knowledge , attitude and practices among parents of children with napkin dermatosis and assess the pattern of napkin dermatosis among children up to 2 years old attending Assiut University Hospital (AUH).
Read the detailed description
Napkin dermatosis, commonly referred to as diaper rash or napkin dermatitis, is a frequent inflammatory skin condition affecting the diaper area of infants and young children, particularly under three years of age [1,2]. It is characterized by erythematous macules, papules, and sometimes erosions or secondary infections. Prevalence rates vary between 4% and 35%, with peak incidence between 8 and 12 months [1-3].Multiple factors contribute to its development, including prolonged exposure to moisture, urine, and feces, which compromise the skin barrier and increase susceptibility to irritants and infections. Interaction of urine with skin bacteria produces ammonia, raising skin pH and promoting irritation [4,5]. Introduction of solid foods can further exacerbate inflammation, and secondary infections, particularly by Candida albicans, may complicate the clinical course [6,7].Caregivers' knowledge, attitudes, and practices are critical in preventing and managing napkin dermatosis. Frequent diaper changes, use of barrier creams, and avoiding irritant products significantly reduce its risk [8-9].Parental knowledge and awareness about proper diaper care, prevention strategies, and early recognition of complications play a pivotal role in reducing the incidence and severity of napkin dermatosis [7]. However, evidence suggests that parental awareness and adherence to recommended practices vary widely, especially in regions lacking structured educational programs [10,11].the rationale for this study is to assess Parental knowledge, attitudes, and practices, and describe the patterns of napkin dermatosis among children attending Assiut University Hospitals, ultimately improving child health and parental care behaviors.
- Conditions
- Napkin Dermatosis
- Keywords
- knowledge of napkin dermatosis, pattern of napkin skin lesion
What is being measured
The primary outcome is the main question the study is designed to answer.
parental knowledge ,attitude and practice regarding napkin dermatosis
the level of knowledge ,attitude and practice of parents and caregivers regarding causes, prevention, and management of napkin dermatosis, expressed as a composite knowledge score obtained from the questionnaire
Measured: At baseline (during recruitment,within study period)
Rate and pattern of napkin dermatosis among children up to 2 years attending Assiut University Hospital
Distribution and frequency of clinical types of napkin dermatosis (e.g., irritant contact dermatitis, candidiasis, bacterial infections, seborrheic dermatitis, etc.).
Measured: Within 12 months of study enrollment
Secondary outcomes (3)
Correlation between parental awareness and severity of napkin dermatosis
Statistical association between caregivers' knowledge, attitude, and practice (KAP) scores and the clinical severity/type of napkin dermatosis in their children.
Measured: At the end of the study (12 months)
Identification of socio-demographic and clinical risk factors
Analysis of potential risk factors for napkin dermatosis, including socio-demographic variables (parental education, income, etc.) and clinical factors (diarrhea, diaper type, hygiene practices)
Measured: Within 12 months of study enrollment.
Frequency of secondary infections associated with napkin dermatosis
Measurement of occurrence of secondary bacterial or fungal infections complicating napkin dermatosis in affected children.
Measured: Within 12 months of study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Napkin DermatosisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 240 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Donia Ahmed zakaria, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07206771
- Sponsor's protocol ID
- napkin dermatosis
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge, Attitudes, and Practices Among Parents of Children With Napkin Dermatosis and Its Patterns in Assiut University Hospitals
- ClinicalTrials.gov ID
- NCT07206771
- Acronym / sponsor ID
- napkin dermatosis
- Conditions
- Napkin Dermatosis
- Keywords
- knowledge of napkin dermatosis, pattern of napkin skin lesion
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 3 Oct 2025 (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.
Evaluate the level of knowledge , attitude and practices among parents of children with napkin dermatosis and assess the pattern of napkin dermatosis among children up to 2 years old attending Assiut University Hospital (AUH).
Detailed description
Napkin dermatosis, commonly referred to as diaper rash or napkin dermatitis, is a frequent inflammatory skin condition affecting the diaper area of infants and young children, particularly under three years of age [1,2]. It is characterized by erythematous macules, papules, and sometimes erosions or secondary infections. Prevalence rates vary between 4% and 35%, with peak incidence between 8 and 12 months [1-3].Multiple factors contribute to its development, including prolonged exposure to moisture, urine, and feces, which compromise the skin barrier and increase susceptibility to irritants and infections. Interaction of urine with skin bacteria produces ammonia, raising skin pH and promoting irritation [4,5]. Introduction of solid foods can further exacerbate inflammation, and secondary infections, particularly by Candida albicans, may complicate the clinical course [6,7].Caregivers' knowledge, attitudes, and practices are critical in preventing and managing napkin dermatosis. Frequent diaper changes, use of barrier creams, and avoiding irritant products significantly reduce its risk [8-9].Parental knowledge and awareness about proper diaper care, prevention strategies, and early recognition of complications play a pivotal role in reducing the incidence and severity of napkin dermatosis [7]. However, evidence suggests that parental awareness and adherence to recommended practices vary widely, especially in regions lacking structured educational programs [10,11].the rationale for this study is to assess Parental knowledge, attitudes, and practices, and describe the patterns of napkin dermatosis among children attending Assiut University Hospitals, ultimately improving child health and parental care behaviors.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged 0-24 months presenting with napkin dermatosis at Assiut University Hospitals outpatient dermatology and pediatric clinics
Key inclusion criteria (2 listed)
- Children aged up to 2 years attending Assuit University Chlidren's Hospital and dermatology outpatient clinics in AUH during the study period , presenting with skin changes in the diaper area.
- Children whose parents and caregivers provide informed consent for participation.
Key exclusion criteria (2 listed)
- parents and caregivers who refuse or are unable to give informed consent.
- Infants on admission , severely ill or immunocompromised
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
parental knowledge ,attitude and practice regarding napkin dermatosis
Time frame: At baseline (during recruitment,within study period)
the level of knowledge ,attitude and practice of parents and caregivers regarding causes, prevention, and management of napkin dermatosis, expressed as a composite knowledge score obtained from the questionnaire
Rate and pattern of napkin dermatosis among children up to 2 years attending Assiut University Hospital
Time frame: Within 12 months of study enrollment
Distribution and frequency of clinical types of napkin dermatosis (e.g., irritant contact dermatitis, candidiasis, bacterial infections, seborrheic dermatitis, etc.).
3 secondary outcomes
Correlation between parental awareness and severity of napkin dermatosis
Time frame: At the end of the study (12 months)
Identification of socio-demographic and clinical risk factors
Time frame: Within 12 months of study enrollment.
Frequency of secondary infections associated with napkin dermatosis
Time frame: Within 12 months of study enrollment
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 3 Oct 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Napkin Dermatosis
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
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Improving the Care of Incontinence-Associated Dermatitis (IAD) Using a Beta-Glucan Cream as a Hydrating and Soothing Agent
Fecal Incontinence, Urinary Incontinence
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Breast Milk Versus Barrier Creams for Diaper Dermatitis in Children Aged 0-24 Months
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Napkin Dermatosis, run by Assiut University.
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 2 inclusion and 2 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 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
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 donia ahmed zakaria, resedent doctor (01094527011, dondonahmed999@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
parental knowledge ,attitude and practice regarding napkin dermatosis (time frame: At baseline (during recruitment,within study period)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Oct 2025.