Actively Recruiting

Age: 32Months - 34Months
All Genders
Healthy Volunteers
NCT04916652

A First-ever Research Collaboration to Characterize MRI Measured Neural Flexibility Development in Chinese Toddlers

Led by Société des Produits Nestlé (SPN) · Updated on 2025-12-03

60

Participants Needed

1

Research Sites

147 weeks

Total Duration

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AI-Summary

What this Trial Is About

The overall objective is to characterize the developmental characteristics of MRI measured neural flexibility, as an index of cognitive flexibility, in Chinese toddlers (32 to 42 months old).

CONDITIONS

Official Title

A First-ever Research Collaboration to Characterize MRI Measured Neural Flexibility Development in Chinese Toddlers

Who Can Participate

Age: 32Months - 34Months
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent has been obtained from the parent/legally acceptable representative.
  • Full-term birth (≥ 37 weeks and ≥ 2.5kg).
  • Typically developing children aged between 32-34 months (2 years 8 months to 2 years 10 months) at enrolment.
  • Neurotypical development as assessed by interview.
  • No major risk factors for learning, neurologic, or psychiatric disorder as assessed by interview (defined as a diagnosed learning, neurologic or psychiatric disorder in a first degree relative such as parents or siblings).
  • For S-26 GOLD or ULTIMA GUM-fed group: daily consumption of S-26 GOLD or ULTIMA GUM for the last 60 days (2 months) and parental desire to continue feeding GUM during the study.
  • For cow's milk-fed group: daily consumption of cow's milk for the last 60 days (2 months) and parental desire to continue feeding cow's milk during the study.
Not Eligible

You will not qualify if you...

  • Delayed birth (> 41 weeks gestation) as reported in medical record.
  • Birth weight < 2500 g or small for gestational age (below the 10th percentile) or large for gestational age (above the 90th percentile) as reported in medical record.
  • History of neurological (e.g., head injury, epilepsy), psychiatric, or developmental disorder in the toddler as assessed by interview.
  • History of diagnosed neurological, psychiatric, or developmental disorder in parents or siblings as assessed by interview.
  • In utero exposure to alcohol abuse or illicit substances as defined by diagnosis of current substance use disorder in the biological mother and relevant medical guidelines.
  • Multiple birth as reported in medical record.
  • Complicated pregnancy (e.g., preeclampsia, gestational diabetes) as assessed by medical interview or record.
  • Abnormal screening laboratory values or studies considered clinically significant by the Investigator (e.g., metabolic disease screening, neonatal bilirubin).

AI-Screening

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Trial Site Locations

Total: 1 location

1

Shanghai Children's Medical Center

Shanghai, Shanghai Municipality, China

Actively Recruiting

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Research Team

J

Joyce Li

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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