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| Name | Class |
|---|---|
| ObvioHealth | INDUSTRY |
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Collection of a panel of stool images from healthy infants/toddlers for the development of a software
To collect at least 200 images per Brussels Infant and Toddler Stool Scale (BITSS) score and at least 200 images of empty (no stool) disposable diapers from healthy infants/toddlers aged 0-24 months for the development of a software
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool pattern | Other | Collection of stool images |
| Measure | Description | Time Frame |
|---|---|---|
| Total Number of Stool Images Collected | Creation of a database containing at least 1600 pictures of individual diapers:
| At least 30 days |
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| Measure | Description | Time Frame |
|---|---|---|
| A Comparison of the Stool Consistency Scores From the Mothers On-study to Re-scores From Mothers (Not Enrolled on Study) Based Only on the Uploaded Images | A comparison of the stool consistency scores from the mothers on-study to re-scores from two mothers (not enrolled on study, Mother #1 and Mother #2) based only on the uploaded images | 30 days |
Inclusion Criteria:
Exclusion Criteria:
Mothers of Infants/Toddlers:
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Healthy subjects aged 0-24 months
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| Name | Affiliation | Role |
|---|---|---|
| Parth Shah, MD | Obvio Health | Principal Investigator |
| Seng Hock Quak, MD | National University Hospital, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ObvioHealth | Orlando | Florida | 32826 | United States | ||
| National University Hospital, Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28360250 | Background | Vandenplas Y, Szajewska H, Benninga M, Di Lorenzo C, Dupont C, Faure C, Miqdadi M, Osatakul S, Ribes-Konickx C, Saps M, Shamir R, Staiano A; BITSS Study Group. Development of the Brussels Infant and Toddler Stool Scale ('BITSS'): protocol of the study. BMJ Open. 2017 Mar 29;7(3):e014620. doi: 10.1136/bmjopen-2016-014620. |
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The mother was to complete an eQuestionnaire for eligibility confirmation and upload 3 separate test images of her infant/toddler's stool via ClaimIt within a window of 10 days. The mother and infant/toddler were enrolled if the test images were successfully uploaded and if they met all inclusion criteria and none of the exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Mother-infant/Toddler Pairs | 96 mother-infant/toddler pairs were enrolled in the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
96 mother-infant/toddler pairs were included in the analysis
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| ID | Title | Description |
|---|---|---|
| BG000 | Mother-infant/Toddler Pairs | 96 mother-infant/toddler pairs were enrolled in the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age for infant, continuous |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Total Number of Stool Images Collected | Creation of a database containing at least 1600 pictures of individual diapers:
| Posted | Number | images | At least 30 days |
|
|
no timeframe as no AE/SAE is collected
This is an observation study to collect stool images. no invasive procedures are involved. at risk of SAE/AE is not collected
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Mother-infant/Toddler Pairs | 96 mother-infant/toddler pairs were enrolled in the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Digital Project Manager | Danone Asia Pacific Holdings | 82281172 | jill.wong@danone.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 12, 2018 | Mar 10, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 6, 2018 | Mar 10, 2020 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 22, 2018 | Aug 5, 2020 | ICF_002.pdf |
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| An Assessment of Mothers' Perceptions of the Usability of the ClaimIt App |
An assessment of mothers' perceptions of the usability of the ClaimIt app with ClaimIt Platform Questionnaire |
| 30 days |
| Singapore |
| 119074 |
| Singapore |
| Mean |
| Full Range |
| months |
|
| Age, Continuous | Age for mother, continuous | Mean | Full Range | years |
|
| Sex: Female, Male | For infant/toddler | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Other Pre-specified | A Comparison of the Stool Consistency Scores From the Mothers On-study to Re-scores From Mothers (Not Enrolled on Study) Based Only on the Uploaded Images | A comparison of the stool consistency scores from the mothers on-study to re-scores from two mothers (not enrolled on study, Mother #1 and Mother #2) based only on the uploaded images | Posted | Number | percentage of agreement | 30 days |
|
|
|
| Other Pre-specified | An Assessment of Mothers' Perceptions of the Usability of the ClaimIt App | An assessment of mothers' perceptions of the usability of the ClaimIt app with ClaimIt Platform Questionnaire | 96 pairs enrolled, 91 completed study, 87 completed the study questionnaire | Posted | Count of Participants | Participants | 30 days |
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