MRI-measured neural flexibility development in Chinese toddlers aged 32–42 months

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study will obtain brain MRI scans to quantify neural flexibility as an index of cognitive flexibility in Chinese toddlers aged 32–42 months and will collect parent-completed BRIEF-P scores to measure executive functions. Participants must be full-term, neurotypical children with at least 60 days of consistent feeding either S-26 GOLD/ULTIMA GUM or cow's milk prior to enrollment and parental consent. Data will be collected at Shanghai Children's Medical Center and sponsored by Société des Produits Nestlé (SPN). The goal is to describe developmental patterns and relationships between MRI measures and behavioral executive function in this specific age and feeding subgroups.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent has been obtained from the parent/legally acceptable representative.
2. Full-term birth (≥ 37 weeks and ≥ 2.5kg)
3. Typically developing Children aged between 32-34 months (2 years 8 months to 2 years10 month of age) at enrolment
4. Neurotypical development as assessed by interview
5. No major risk factors for learning, neurologic, or psychiatric disorder as assessed by interview \[defined as a diagnosed learning neurologic or psychiatric disorder in a first degree relative (e.g. parents, siblings)\].
6. 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

Exclusion Criteria:

1. Delayed birth ( \> 41 weeks gestation) as reported in medical record
2. 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
3. History of neurological (e.g., head injury, epilepsy), psychiatric or developmental disorder in the toddler as assessed by interview
4. History of diagnosed neurological (e.g., head injury, epilepsy), psychiatric or developmental disorder in parents or siblings, as assessed by interview
5. 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
6. Multiple birth as reported in medical record
7. Complicated pregnancy (e.g., preeclampsia, gestational diabetes) as assessed by medical interview/ medical record
8. 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's running

• Shanghai Children's Medical Center
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Fan Jiang — Shanghai Children's Medical Center
• Study coordinator: Joyce Li
• Email: joyce.li@rd.nestle.com
• Phone: +86 15810125435

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.