Growth; Stunting, Nutritional Clinical Trial
— GAINOfficial title:
Assessing the Use of a Growth Artificial Intelligence Algorithm for Estimating the leNgth of Children in Real-world Setting
NCT number | NCT05079776 |
Other study ID # | SBB20R&31696 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 8, 2021 |
Est. completion date | June 20, 2022 |
Verified date | July 2022 |
Source | Danone Asia Pacific Holdings Pte, Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
An exploratory study to explore the possibility of using computer vision algorithms to estimate a child's length using images taken by a healthcare professional or parents.
Status | Completed |
Enrollment | 200 |
Est. completion date | June 20, 2022 |
Est. primary completion date | March 8, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 18 Months |
Eligibility | Inclusion Criteria: 1. Children aged 0 to 18 months old. 2. Parent(s) should have access to the internet and a smartphone or tablet to complete study questionnaires, take images and upload images. 3. Parent(s) should be able to comprehend the content of the study and to complete the study questionnaires in English. 4. Written consent from parent. Exclusion Criteria: 1. Parent(s) incapable of completing the study questionnaires and uploading of the images using smart phone or tablet with internet. 2. Children unable to undergo length measurement (e.g. children with structural abnormalities of the lower limbs or orthopedic conditions such as club foot, hip dysplasia, etc). |
Country | Name | City | State |
---|---|---|---|
Singapore | KK Women's and Children's Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Danone Asia Pacific Holdings Pte, Ltd. | KK Women's and Children's Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Accuracy of the length AI | Accuracy of the length AI in a clinic and in a home setting, derived from:
The length AI prediction from images collected The physical length measurement of subjects |
2 days | |
Secondary | Investigator's assessment on collection of images | Investigator's assessment on the ease of collecting the images [Very Easy, Easy, Normal, Difficult, Very Difficult] | 2 days | |
Secondary | Parental acceptability of the length AI | Parental acceptability of length AI assessed via the study questionnaire [Very useful, useful, neutral, not useful, very not useful] | 2 days | |
Secondary | Investigators' (or delegates) acceptability of length AI | Investigators' (or delegates) likelihood of using the length AI assessed via the study questionnaire [Very Likely, Likely, Neutral, Unlikely, Very Unlikely] | 2 days |
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