Assessing a Length Artificial Intelligence Algorithm to Estimate Length of Children (GAIN)

Assessing the Use of a Growth Artificial Intelligence Algorithm for Estimating the leNgth of Children in Real-world Setting

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.

Study Overview

• Status: Completed
• Conditions: Growth; Stunting, Nutritional
• Intervention / Treatment: Other: Physical length measurement

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • KK Women's and Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 1 year (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children between 0-18 months of age with no physical deformities.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children aged 0-18 months of age; Children aged 0-18 months of age with no structural abnormalities of the lower limbs or orthopedic conditions	Other: Physical length measurement; Physical length will be measured and images will be collected for AI to estimate the length

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Danone Asia Pacific Holdings Pte, Ltd.
• Collaborators: KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Actual): March 8, 2022
• Study Completion (Actual): June 20, 2022

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 4, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 27, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: growth; artificial intelligence; algorithm; length
• Additional Relevant MeSH Terms: Pathologic Processes; Growth Disorders
• Other Study ID Numbers: SBB20R&31696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No