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OpenTrials
Active, Not Recruiting

NCT Number: NCT06920550

A Growth Artificial Intelligence Algorithm for leNgth and Weight Study

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Length Body Weight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight

Age range

0 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Franciscus Gasthuis, Rotterdam, Netherlands

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)).
  • Research staff's uncertainty about the caregiver's ability or willingness to complete the study according to the instructions

Treatment and study plan

Primary outcomes

  1. Accuracy length AI

    Time frame: Date of enrolment, at baseline

    Accuracy 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).

  2. Accuracy caregiver length

    Time frame: Date of enrolment, at baseline

    Accuracy 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.

  3. Accuracy caregiver vs AI length

    Time frame: Date of enrolment, at baseline

    Accuracy of the caregiver measurements (self preferred methodology in cm) vs Length AI by same parameters as mentioned in the first primary outcome measure.

Secondary outcomes

  1. Accuracy weight AI

    Time frame: Date of enrolment, at baseline

    Accuracy 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).

  2. Accuracy caregiver weight

    Time frame: Date of enrolment, at baseline

    Accuracy 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.

  3. Ease of use tool

    Time frame: Date of enrolment, at baseline

    The 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.

  4. Acceptability tool

    Time frame: Date of enrolment, at baseline

    The expectation and acceptability of the tool "GAINS app" on a personal mobile device of the caregiver, assessed via a custom made user experience questionnaire.

Sponsors and collaborators

Lead sponsor

Nutricia Research

Industry

Registry information

Acronym: GAINS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 9, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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