Trial · NCT03409367
Outcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Provider-diagnosed Atopic Dermatitis | up to 24 months | Diagnosis of atopic dermatitis recorded by primary care clinicians in health records by 24 (+/- 3) months of age. Multiple imputation of 199 missing outcomes (92 intervention, 107 control). All ITT with multiple imputation for participants with absent outcome data. Numbers represent participants per randomized arm, regardless of adherence to instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses. | Participants with imputed values | NUMBER |
| SECONDARY | Parent Report of Atopic Dermatitis | up to 24 months | Multiple imputation of 111 outcomes considered missing when parent did not respond at 21 or 24 months and no diagnosis had been reported at earlier contacts. All ITT with multiple imputation for 9% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses. | Participants with imputed values | NUMBER |
| SECONDARY | Atopic Dermatitis by UK Working Party Criteria | up to 24 months | Multiple imputation of 148 outcomes considered missing when parent did not respond at 24 months and the previous 12-month contact was not positive for AD by these criteria. All ITT with multiple imputation for 12% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses. | Participants with imputed values | NUMBER |
| SECONDARY | Atopic Dermatitis by Children's Eczema Questionnaire | up to 24 months | Multiple imputation of 136 outcomes considered missing when parent did not respond at 24 months and the previous 12-month contact was not positive for AD by these criteria. All ITT with multiple imputation for 11% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses. | Participants with imputed values | NUMBER |
| SECONDARY | Atopic Dermatitis With Prescription or Over-the-counter Therapies in Chart | up to 24 months | Multiple imputation of 199 missing outcomes. All ITT with multiple imputation for 16% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses. | Participants with imputed values | NUMBER |
| SECONDARY | Atopic Dermatitis With or Without Prescription or Over-the-counter Therapies in Chart (Ordinal) | Up to 24 months | All ITT with multiple imputation for 16% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses. | Participants with imputed values | NUMBER |
| SECONDARY | Prescribed or Over-the-counter Topical Skin Medication by Parent Report | up to 24 months | Participants with (a) a parent report of provider diagnosis from an annual questionnaire or quarterly contact or (b) if no diagnosis, a parent response to a quarterly or annual contact at 21 to 24 months. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | participants | NUMBER |
| SECONDARY | Skin Infections Diagnosed and Recorded in Chart Review | up to 24 months | All participants with (a) at least one primary care visit between 20 and 27 months of age or (b) a skin infection diagnosis earlier than 20 months. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Provider-diagnosed Asthma | up to 24 months | All participants with (a) at least one primary care visit between 20 and 27 months of age or (b) asthma diagnosis earlier than 20 months. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | participants | NUMBER |
| SECONDARY | Severity of AD Symptoms Using POEM | 12 months of age | Respondents to 12-month questionnaires who reported a provider diagnosis of AD in the same questionnaire or at a quarterly contact, or whose response to the CEQ indicated AD. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | score on a scale | MEDIAN |
| SECONDARY | Severity of AD Symptoms Using POEM | 24 months of age | Respondents to 24-month questionnaires who reported a provider diagnosis of AD in the same or previous annual questionnaire or at a quarterly contact, or whose response to the CEQ indicated AD. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | score on a scale | MEDIAN |
| SECONDARY | Severity of AD Symptoms Using IDQoL | 12 months | Respondents to 12-month questionnaires who reported a provider diagnosis of AD in the same questionnaire or at a quarterly contact, or whose response to the CEQ indicated AD. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | score on a scale | MEDIAN |
| SECONDARY | Severity of AD Symptoms Using IDQoL | 24 months | Respondents to 24-month questionnaires who reported a provider diagnosis of AD in the same questionnaire or at a quarterly contact, or whose response to the CEQ indicated AD. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | score on a scale | MEDIAN |
| SECONDARY | Food Allergy Symptoms | 12 months, 24 months or both | Respondents who answered items about immediate food allergy symptoms. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | participants | NUMBER |
| SECONDARY | Food Allergy Diagnosis With Positive Test | up to 24 months | Respondents who answered items about immediate food allergy symptoms. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | participants | NUMBER |
| SECONDARY | Primary Outcome of Provider-diagnosed Atopic Dermatitis | up to 12 months | Infants with diagnosis of atopic dermatitis at \<=12 months or with no diagnosis and at least one primary care visit in the health record after 9 months of age. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Provider-diagnosed Atopic Dermatitis at 18 Months | up to 18 months | Infants with diagnosis of atopic dermatitis at \<=18 months or with no diagnosis and at least one primary care visit in the health record after 15 months of age. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Provider-diagnosed Atopic Dermatitis - Low-risk Population | up to 24 months | All ITT with multiple imputation for 19% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses. | Participants with imputed values | NUMBER |
| OTHER_PRE_SPECIFIED | Provider-diagnosed Atopic Dermatitis - High-risk Population | up to 24 months | All ITT with multiple imputation for 13% of participants with absent outcome data. Numbers represent participants according to arm randomized, regardless of adherence to study instructions. Counts were summarized over 15 multiple imputation datasets generated by chained equations using baseline and follow-up survey responses. | Participants with imputed values | NUMBER |
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
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GET https://conductscience.org/api/trials/v1/NCT03409367/outcomes