Improving Artificial Intelligence-derived Algorithms for Estimating Length and Weight in NEonateS and infanTs up to 6 Months of Age (NEST)

NCT07514182 | Recruiting

• 1 other identifier: 25REX0090391
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The NEST study is a prospective, observational research study designed to collect clinical measurements and image data to develop and evaluate artificial intelligence (AI)-derived algorithms for estimating anthropometric parameters in neonates and young infants. The study focuses on infants from birth up to 6 months of age and aims to assess the accuracy of AI-based estimations of length, weight, and head circumference using photographs and/or video recordings captured during routine clinical care. These AI-derived measurements will be compared against standard clinical measurements obtained by trained healthcare professionals in neonatal and infant care settings.

Conditions

Growth; Neonates; AI (Artificial Intelligence)

Keywords

Neonates; Infants; Neonatal Growth; Infant Growth assessment; Anthropometric measurements; Infant length measurements; Infant weight measurement; Head Circumference; Artificial Intelligence; Image based assessment; Digital Health; Photographs and video recordings; Neonatal intensive care unit; Special Care nursery; Observational study; Proof of concept study; Growth monitoring

Outcome Measures

Primary Outcomes (1)

• To evaluate the accuracy of the algorithm to estimate length (in cm)

  The primary outcome is the proof-of-concept accuracy of an artificial intelligence (AI)-based algorithm for estimating infant length in a neonatal intensive care unit (NICU) or special care nursery (SCN) setting. AI-derived length estimates (in centimeters) obtained from supine images and/or videos are compared with standard clinical length measurements performed by trained investigators using World Health Organization (WHO)-recommended techniques. Accuracy is evaluated using a composite metric that includes bias, mean absolute error, mean absolute percentage error, and the distribution of absolute percentage errors at predefined thresholds.

  From enrolment (after informed consent) until discharge from NICU/SCN, up to a maximum of 10 weeks

Secondary Outcomes (1)

• To evaluate the mean absolute error of the algorithm to estimate weight (in kg)

  From enrolment (after informed consent) until discharge from NICU/SCN, up to a maximum of 10 weeks

Other Outcomes (4)

• To evaluate the mean absolute error of the algorithm to estimate head circumference (in cm)

  From enrolment (after informed consent) until discharge from NICU/SCN, up to a maximum of 10 weeks

• Ease of image collection by investigator for each participant (Very Easy, Easy, Normal, Difficult, Very difficult]

  Once per participant, prior to discharge from NICU/SCN (at the conclusion of study participation) [1 day]

• Expected level of accuracy by the investigator for length [Less than or equal to 1 cm, less than or equal to 2 cm, less than or equal to 3 cm, less than or equal to 4 cm, less than or equal to 5 cm, more than 5 cm]

  Per participant, at the conclusion of study participation (prior to discharge from NICU/SCN) [1 day]

Study Arms (1)

Very preterm infants, moderate to late preterm infants, and term infants

This cohort includes neonates and infants from birth up to 6 months of age, encompassing very preterm (28-31 weeks gestation), moderate to late preterm (32-36 weeks gestation), and term infants (≥37 weeks gestation). Participants are enrolled prospectively during their stay in neonatal or infant care settings. This is an observational study; no investigational product or therapeutic intervention is administered. Study procedures involve the collection of routine clinical anthropometric measurements (length, weight, and head circumference) and the capture of photographs and/or video recordings for the development and evaluation of artificial intelligence-derived algorithms. All data are collected in conjunction with standard clinical care.

Eligibility Criteria

• Age: 0 Days - 6 Months
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population comprises neonates and infants from birth up to 6 months of age who are admitted to a neonatal intensive care unit (NICU) or special care nursery (SCN). Eligible participants include very preterm, moderate to late preterm, and term infants who meet the study's inclusion criteria and whose parents or legally acceptable representatives provide written informed consent. Participants are enrolled during their NICU/SCN stay and followed prospectively for the duration of their hospitalization, up to a maximum of 10 weeks. The study collects anthropometric measurements and image and video data in conjunction with routine clinical care.

You may qualify if:

• Infants up from birth up to 6 months of postnatal age (including neonates) who have been admitted to the NICU or SCN at the time of screening
• Parent(s) should be able to comprehend the content of the study and be willing for their child to undergo video and photo recording, and to allow access to their blood sampling results (haemoglobin) taken as part of standard clinical practice
• Written consent from parents and/or legally acceptable representative

You may not qualify if:

• Infants who were born with gestational age of less than 28 weeks of gestational age
• Infants who are intubated (i.e., endotracheal, nasotracheal intubation) at the time of screening
• The investigator considers for any reason that the participant would not be suitable for the study
• The participant has an existing medical condition that would prevent standardised measurement of length and/or head circumference e.g. structural abnormality of the lower limbs, orthopaedic conditions, hydrocephalus
• Employees and/or children/family members or relatives of employees of Danone Global Research \& Innovation Center, Danone Asia Pacific Holdings Pte Ltd, or the participating site

Sponsors & Collaborators

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

Study Sites (1)

KK Women's and Children's Hospital

Singapore, Singapore

RECRUITING

Study Officials

• Bin Huey Quek, MBBS

  KK Women's and Children's Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amilia Sng, Senior Digital Health R&I Study Manager, MSc Pharmacology

CONTACT

+6594773284; amilia.sng@danone.com

Kimberley Tan, Clinical Research Associate, BSc

CONTACT

+6598359119; kimberley.tan@external.danone.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 7, 2026
• Study Start: March 26, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)