LengthGAINSNCT06920550
A Growth Artificial Intelligence Algorithm for leNgth and Weight Study
An observational study of Length and Weight, run by Nutricia Research at 4 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 24 monthsHealthy volunteers can take part
- How many people
- 250 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 20 Dec 2024to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children aged 0 to 24 months.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Spain2 sites
Hospital Universitario Puerta del Mar
Cadiz
Hospital Universitario de Jerez dela Frontera
Jerez de la Frontera
About this 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.
- Keywords
- artificial intelligence, length, weight, algorithm
- Medical subject headings
- Body Weight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children 0-24 months | Children aged 0-24 months of age with no structural abnormalities of the lower limbs or orthopedic conditions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy length AI
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).
Measured: Date of enrolment, at baseline
Accuracy caregiver length
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.
Measured: Date of enrolment, at baseline
Accuracy caregiver vs AI length
Accuracy of the caregiver measurements (self preferred methodology in cm) vs Length AI by same parameters as mentioned in the first primary outcome measure.
Measured: Date of enrolment, at baseline
Secondary outcomes (4)
Accuracy weight AI
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).
Measured: Date of enrolment, at baseline
Accuracy caregiver weight
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.
Measured: Date of enrolment, at baseline
Ease of use tool
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.
Measured: Date of enrolment, at baseline
Acceptability tool
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.
Measured: Date of enrolment, at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2025
- Study start20 Dec 2024
- Primary completion19 Feb 2026
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LengthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nutricia Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920550
- Sponsor's protocol ID
- 23REX0058267
- Acronym
- GAINS
- Status last verified
- May 2026
- First submitted
- 11 Dec 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not applicable due to the nature of the project
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Growth Artificial Intelligence Algorithm for leNgth and Weight Study
- ClinicalTrials.gov ID
- NCT06920550
- Acronym / sponsor ID
- GAINS / 23REX0058267
- Keywords
- artificial intelligence, length, weight, algorithm
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Nutricia ResearchIndustry (pharma, biotech, devices)
- Study start
- 20 Dec 2024 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 9 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children 0-24 months | – | –Children aged 0-24 months of age with no structural abnormalities of the lower limbs or orthopedic conditions |
Who may qualify
- Ages
- 0 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children aged 0 to 24 months.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
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.
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.
4 secondary outcomes
Accuracy weight AI
Time frame: Date of enrolment, at baseline
Accuracy caregiver weight
Time frame: Date of enrolment, at baseline
Ease of use tool
Time frame: Date of enrolment, at baseline
Acceptability tool
Time frame: Date of enrolment, at baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No. Not applicable due to the nature of the project
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Length and Weight, run by Nutricia Research at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Netherlands, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy length AI (time frame: Date of enrolment, at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.