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

Recruiting now

Conditions studied: Growth & Development, Brain

In brief

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).

Key facts

Study ID

NCT04916652

Run by

Société des Produits Nestlé (SPN)

People needed

60

Starts

2024-04-06

Expected to finish

2027-02-01

Last updated by the study team

2025-12-03

Who can join

Age: 3 and older, up to 3. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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 years10 month of age) 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 (e.g. parents, siblings)].
• Dietary requirement detailed below:
• S-26 GOLD or ULTIMA GUM--fed group:
• I. Daily consumption of S-26 GOLD or ULTIMA GUM for the last 60 days (2 months) II. Desire of the parent to continue feeding GUM during the course of the study
• Cow's milk-fed group:
• I. Daily consumption of cow's milk or for the last 60 days (2 months) II. Desire of the parent to continue feeding cow's milk during the course of the study

You may not qualify if…

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

Where it is running

• Shanghai Children's Medical Center — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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