| Registry | NCT06920550, acronym GAINS |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 250 (Estimated) |
| Sponsor | Nutricia Research (Industry) |
| Conditions | Length, Weight |
| Dates | start 2024-12-20, primary completion 2026-02-19, completion 2026-07-31 (estimated), first posted 2025-04-09, last updated 2026-05-22 |
| Locations | 4 sites in Netherlands, Poland, Spain |
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All trials for Length All trials for Weight
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Children 0-24 months | Children aged 0-24 months of age with no structural abnormalities of the lower limbs or orthopedic conditions |
Sex: All, ages: 0 Months to 24 Months, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Franciscus Gasthuis | Rotterdam | Netherlands | |
| Ginemedica | Wroclaw | Poland | |
| Hospital Universitario Puerta del Mar | Cadiz | Spain | |
| Hospital Universitario de Jerez dela Frontera | Jerez de la Frontera | Spain |