Trial · NCT03409367
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Provider-diagnosed Atopic Dermatitis | up to 24 months | The cumulative incidence of AD as recorded in health records. Trained clinicians will assess for AD at each clinic visit and record in the health record. |
| Secondary | Parent Report of Atopic Dermatitis | up to 24 months | Parent or guardian reports that a clinician has diagnosed their child with atopic dermatitis (eczema) at any quarterly contact up to 24 months of age. |
| Secondary | Atopic Dermatitis by UK Working Party Criteria | up to 24 months | Parental report of AD using UK Working Party criteria. Parent responds "yes" to all parts of a modified version of the UK Working Party criteria at 12 and/or 24 month. Criteria include an itchy rash in flexural areas, generally dry skin, and asthma or hay fever in a first-degree relative. |
| Secondary | Atopic Dermatitis by Children's Eczema Questionnaire | up to 24 months | AD as diagnosed by the Children's Eczema Questionnaire (CEQ). Parent response to 3 CEQ questions is consistent with AD at 12 and/or 24 months of age. |
| Secondary | Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart | up to 24 months | Cumulative incidence of provider-diagnosed AD requiring prescription or over-the-counter therapies from chart review. Health records at primary care practice includes both a diagnosis of AD and prescription and/or over-the-counter (OTC) therapies. Prescription therapies could be steroids, calcineurin inhibitors, crisaborole, or antibacterials. OTC therapies could be steroids or antihistamines. |
| Secondary | Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal) | Up to 24 months | Ordinal coding of diagnosis of atopic dermatitis (eczema) in primary care health records, coded as none, eczema without prescription or over-the-counter (OTC) topical therapies, eczema with OTC only, or eczema with prescription therapies. Prescription therapies could be steroids, calcineurin inhibitors, crisaborole, or antibacterials. OTC therapies could be steroids or antihistamines. |
| Secondary | Prescribed or Over-the-counter Topical Skin Medication by Parent Report | up to 24 months | Ordinal formulation of parent report: no AD, AD not treated with steroidal or non-steroidal cream or ointment ("therapy"), AD treated with over-the-counter (OTC) therapy, AD treated with prescription therapy. AD could be reported on annual questionnaires or quarterly contacts. Therapies reported on annual questionnaires. |
| Secondary | Skin Infections Diagnosed and Recorded in Chart Review | up to 24 months | Chart outcome for provider diagnosis or medications associated with skin infections, including topical antibiotics. Skin infection diagnoses include impetigo, candida, wart/verruca, molluscum, or herpes simplex. |
| Secondary | Provider-diagnosed Asthma | up to 24 months | Health records at primary care practice include at least one diagnosis of asthma. |
| Secondary | Severity of AD Symptoms Using POEM | 12 months of age | Patient-Oriented Eczema Measure (POEM) score, elicited from families of infants who reported AD diagnosis at this or any previous contact or whose CEQ response indicated AD. The POEM has seven items and ranges from 0 to 28, with higher scores reflecting more severe symptoms of AD. |
| Secondary | Severity of AD Symptoms Using POEM | 24 months of age | Patient-Oriented Eczema Measure (POEM) score, elicited from families of infants who reported AD diagnosis at this or any previous contact or whose CEQ response indicated AD. The POEM has seven items and ranges from 0 to 28, with higher scores reflecting more severe symptoms of AD. |
| Secondary | Severity of AD Symptoms Using IDQoL | 12 months | Symptom severity as reflected by the Infant Dermatology Quality of Life Instrument (IDQoL) elicited from families of infants who reported AD diagnosis at this or any previous contact or whose CEQ response indicated AD. The IDQoL has 12 items and ranges from 0-37 with higher scores reflecting greater adverse effect of AD on quality of life |
| Secondary | Severity of AD Symptoms Using IDQoL | 24 months | Symptom severity as reflected by the Infant Dermatology Quality of Life Instrument (IDQoL) elicited from families of infants who reported AD diagnosis at this or any previous contact or whose CEQ response indicated AD. The IDQoL has 12 items and ranges from 0-37 with higher scores reflecting greater adverse effect of AD on quality of life |
| Secondary | Food Allergy Symptoms | 12 months, 24 months or both | Parent reports immediate food allergy reaction in child at 12- or 24-month questionnaire, or both. |
| Secondary | Food Allergy Diagnosis With Positive Test | up to 24 months | Parent reports a provider diagnosis of and a positive test for food allergy at 12- or 24-month questionnaire, or both. |
| Secondary | Primary Outcome of Provider-diagnosed Atopic Dermatitis | up to 12 months | Diagnosis of atopic dermatitis (eczema) recorded by primary care providers in health records up to 12 months of age (rather than 24 months). |
| Secondary | Provider-diagnosed Atopic Dermatitis at 18 Months | up to 18 months | Diagnosis of atopic dermatitis (eczema) recorded by primary care providers in health records up to 18 months of age. |
| Other | Provider-diagnosed Atopic Dermatitis - Low-risk Population | up to 24 months | Subgroup population: In the subgroup of participants who did not report atopic dermatitis in a first-degree relative, diagnosis of atopic dermatitis (eczema) recorded by primary care providers in health records |
| Other | Provider-diagnosed Atopic Dermatitis - High-risk Population | up to 24 months | Subgroup population: In the subgroup of participants who reported atopic dermatitis in a first-degree relative, diagnosis of atopic dermatitis (eczema) recorded by primary care providers in health records |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03409367/registered