Actively Recruiting
Research Collaboration to Study Brain Flexibility Development Using MRI in Chinese Toddlers Aged 32 to 42 Months
Led by Société des Produits Nestlé (SPN) · Updated on 2025-12-03
60
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the development of neural flexibility, which reflects cognitive flexibility, in Chinese toddlers aged 32 to 42 months. The goal is to understand how cognitive flexibility evolves during this age by measuring brain activity using MRI scans and assessing executive functions like inhibition, shifting attention, emotional control, working memory, and planning. These functions are evaluated using a standardized rating scale called the Global Executive Composite (GEC) from the BRIEF-P assessment. The study involves using MRI, a safe and non-invasive imaging technology, to capture detailed brain information. Participants will undergo MRI scans at the start of the study and again 42 months later to track changes in neural flexibility over time. Executive functions will be measured at the same time points using the GEC score. This research builds on similar projects studying brain development in infants and toddlers internationally. During the study, parents will provide informed consent and confirm their child's eligibility. The toddlers will be assessed through interviews and monitored for neurodevelopmental progress. Researchers will collect data on neural flexibility and executive function scores at baseline and after 42 months. The study includes careful screening for medical history and developmental status to ensure appropriate participation. Safety is monitored, and the entire involvement period spans from initial assessment to the 42-month follow-up.
CONDITIONS
Official Title
A First-ever Research Collaboration to Characterize MRI Measured Neural Flexibility Development in Chinese Toddlers
Who Can Participate
Eligibility Criteria
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.
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
Research Team
J
Joyce Li
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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