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

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

This project will use MRI and parent-rated tests to see if neural flexibility and executive function differ in typically developing Chinese toddlers aged 32–42 months, including groups fed S-26 GOLD/ULTIMA GUM versus cow's milk.

Quick facts

• Study type: Observational
• Enrollment: 60 (estimated)
• Ages: 32 Months to 34 Months
• Sex: All
• Sponsor: Société des Produits Nestlé (SPN) (Industry-sponsored)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT04916652 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Typically developing, full-term Chinese toddlers aged 32–42 months with no major family history of learning, neurologic, or psychiatric disorders and with at least 60 days of consistent S-26 GOLD/ULTIMA GUM or cow's milk feeding, with parent consent, are ideal candidates.

Not a fit: Children born preterm, with known developmental disorders, significant family risk for neurological/psychiatric conditions, or those outside the 32–42 month age window or without the specified feeding history are unlikely to benefit from this study's findings.

Why it matters

Potential benefit: If successful, the study could identify early brain markers of cognitive flexibility and inform early nutritional or developmental guidance for toddlers.

How similar studies have performed: Prior MRI work has linked neural flexibility and executive function in older children, but MRI characterization in Chinese toddlers at this age and the specific feeding-group comparison is relatively novel.

Eligibility criteria

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 this trial is running

Shanghai, Shanghai Municipality

• 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

Conditions Growth & Development; Brain