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A Growth Artificial Intelligence Algorithm for leNgth and Weight Study

A Growth Artificial Intelligence Algorithm for leNgth and Weight Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06920550
Acronym
GAINS
Enrollment
250
Registered
2025-04-09
Start date
2024-12-20
Completion date
2026-07-31
Last updated
2026-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Length, Weight

Keywords

artificial intelligence, length, weight, algorithm

Brief summary

This is a data collection and machine learning accuracy testing project that aims to a) collect training data to enhance, by machine learning, an artificial intelligence (AI) algorithm for measuring length in infants and young children and b) test the accuracy of the AI algorithm by comparing the AI predicted length with the gold standard measured length. Images and videos will be collected by care givers and healthcare professionals, together with physical length measurements. These data will be used to train the AI algorithm and to explore potential improvements. Other data to be collected is user experience feedback.

Interventions

None listed

Sponsors

Nutricia Research
Lead SponsorINDUSTRY

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
0 Months to 24 Months
Healthy volunteers
Yes

Inclusion criteria

1. Infants/young children aged 0 to 24 months old at enrolment; 2. Caregiver(s) have access to the internet and a smartphone or tablet to complete questionnaires, take images and videos, and upload these; 3. Written informed consent from one or both caregivers (according to local laws) or legally acceptable representative(s) aged ≥ 18 years at enrolment.

Exclusion criteria

1. Children unable to undergo length or weight measurements when applying standardized techniques recommended by the WHO (e.g. infants/children with structural abnormalities of the lower limbs or orthopaedic conditions (e.g. club foot, hip dysplasia)). 2. Research staff's uncertainty about the caregiver's ability or willingness to complete the study according to the instructions

Design outcomes

Primary

MeasureTime frameDescription
Accuracy length AIDate of enrolment, at baselineAccuracy of the Length AI vs length gold standard (WHO methodology with length board in cm) assessed using several different parameters: the bias (cm), agreement and reliability measures, mean absolute error (cm), mean absolute percentage error (%), percentiles of the absolute error (cm), and root mean square error (cm).
Accuracy caregiver lengthDate of enrolment, at baselineAccuracy of the caregiver measured length (own preferred methodology in cm) vs gold standard measured length (WHO methodology with length board in cm), assessed by same parameters as mentioned in the first primary outcome measure.
Accuracy caregiver vs AI lengthDate of enrolment, at baselineAccuracy of the caregiver measurements (self preferred methodology in cm) vs Length AI by same parameters as mentioned in the first primary outcome measure.

Secondary

MeasureTime frameDescription
Accuracy weight AIDate of enrolment, at baselineAccuracy of the Weight AI vs weight gold standard (WHO methodology with digital scale and tared weighing in kg) assessed using several different parameters: the bias (kg), agreement and reliability measures, mean absolute error (kg), mean absolute percentage error (%), percentiles of the absolute error (kg), and root mean square error (kg).
Accuracy caregiver weightDate of enrolment, at baselineAccuracy of the caregiver measured weight (self preferred methodology in kg) vs weight gold standard (WHO methodology with digital scale and tared weighing in kg), assessed using several different parameters as mentioned in the first secondary outcome measure.
Ease of use toolDate of enrolment, at baselineThe ease of taking images and videos with the tool "GAINS app" on personal mobile device of the caregiver, assessed via a custom made user experience questionnaire.
Acceptability toolDate of enrolment, at baselineThe expectation and acceptability of the tool "GAINS app" on a personal mobile device of the caregiver, assessed via a custom made user experience questionnaire.

Countries

Netherlands, Poland, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 23, 2026