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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2022
Source Danone Asia Pacific Holdings Pte, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

This is an exploratory, observational, pilot study that aims to evaluate the performance of a Length Artificial Intelligence (LAI) algorithm in a real world setting. Images will be collected by parents or healthcare professionals, together with physical length measurements. This data will be used to evaluate the accuracy of the algorithm and to explore potential improvements. Data on the acceptance and experience of the using the algorithm will be collected for improvements.


Recruitment information / eligibility

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).

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Physical length measurement
Physical length will be measured and images will be collected for AI to estimate the length

Locations

Country Name City State
Singapore KK Women's and Children's Hospital Singapore

Sponsors (2)

Lead Sponsor Collaborator
Danone Asia Pacific Holdings Pte, Ltd. KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

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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