Healthy
Conditions
Brief summary
Collection of a panel of stool images from healthy infants/toddlers for the development of a software
Detailed description
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
Interventions
OTHERStool pattern
Collection of stool images
Sponsors
ObvioHealth
Danone Asia Pacific Holdings Pte, Ltd.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 24 Months
Healthy volunteers
Yes
Inclusion criteria
1. Healthy infants/toddlers (0-24 months of age at time of enrollment) 2. Informed consent from mother ≥21 years of age 3. In-home access to reliable internet connections; a mobile device suitable for electronic communication; and a device suitable for capturing and transmitting high-quality electronic images as per the PI's discretion 4. Infant/toddler consumes standard, age-appropriate food (breast milk; formula; commercial/homemade baby, table or finger food) 5. Based on the number of stools already acquired per relevant strata at time of enrollment, infant/toddler may or may not be required to regularly produce stools scored as a Score 1, 2, 6 or 7
Exclusion criteria
Mothers of Infants/Toddlers: 1. The use of cloth diapers (mothers must commit to using disposable diapers for the duration of the study) 2. Known to have a significant condition (including during pregnancy) that might interfere with the study compliance, as per PI's clinical judgment 3. Deemed likely to be non-compliant with the study protocol, as per PI's clinical judgment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Stool Images Collected | At least 30 days | Creation of a database containing at least 1600 pictures of individual diapers: * 200 images of diapers with stool per each score (BITSS types 1 to 7) * 200 images of empty (no stool) disposable diapers |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 30 days | 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 |
| An Assessment of Mothers' Perceptions of the Usability of the ClaimIt App | 30 days | An assessment of mothers' perceptions of the usability of the ClaimIt app with ClaimIt Platform Questionnaire |
Countries
Singapore, United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Mother-infant/Toddler Pairs 96 mother-infant/toddler pairs were enrolled in the study | 96 |
| Total | 96 |
Baseline characteristics
| Characteristic | Mother-infant/Toddler Pairs | — |
|---|---|---|
| Age, Continuous Infant/Toddler | 13.3 months | — |
| Age, Continuous | 30.2 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 96 participants | — |
| Sex: Female, Male Female | 50 Participants | — |
| Sex: Female, Male Male | 46 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Total Number of Stool Images Collected
Creation of a database containing at least 1600 pictures of individual diapers: * 200 images of diapers with stool per each score (BITSS types 1 to 7) * 200 images of empty (no stool) disposable diapers
Time frame: At least 30 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mother-infant/Toddler Pairs | Total Number of Stool Images Collected | 2731 images |
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
Time frame: 30 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Mother-infant/Toddler Pairs | 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 | Agreement with Mother #1 | 58.0 percentage of agreement |
| Mother-infant/Toddler Pairs | 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 | Agreement with Mother #2 | 48.5 percentage of agreement |
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
Time frame: 30 days
Population: 96 pairs enrolled, 91 completed study, 87 completed the study questionnaire
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mother-infant/Toddler Pairs | An Assessment of Mothers' Perceptions of the Usability of the ClaimIt App | Difficult to score stool pictures: No | 78 Participants |
| Mother-infant/Toddler Pairs | An Assessment of Mothers' Perceptions of the Usability of the ClaimIt App | Difficult to score stool pictures: Yes | 9 Participants |