A First-ever Research Collaboration to Characterize MRI Measured Neural Flexibility Development in Chinese Toddlers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: MRI.
- Who it may be relevant to
- Registry conditions: Growth & Development, Brain. Basic parameters: 32 months — 34 months · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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).
Detailed description
The primary objective of this clinical study is to characterize in Chinese toddlers ages 32 - 42 months old the developmental characteristics of MRI measured neural flexibility, as an index of cognitive flexibility, and to assess a range of executive functions (inhibit, shift, emotional control, working memory, plan/organize) using the Global Executive Composite summary score obtained from the BRIEF-P standardized rating scale.
Interventions
- Radiation MRI
MRI is a safe, non-invasive, cutting edge imaging technology widely used to study the human brain both internationally (NIH connectome project) and in China (China Brain Project). The Baby Connectome Project (BCP) led by NIH scientists has begun data collection on the structural and functional brain development among American infants (Howell, Styner et al. 2019).
Primary outcome measures
- Neural flexibility [Time frame: at baseline and 42 months after baseline]
- Global Executive Composite (GEC) score [Time frame: at baseline and 42 months of age]
Secondary outcome measures (12)
- Brain structure (brain regions volume) [Time frame: at baseline and 42 months of age]
- Brain structure (cortical surface area) [Time frame: at baseline and 42 months of age]
- Brain structure (cortical thickness) [Time frame: at baseline and 42 months of age]
- Brain structure (myelination) [Time frame: at baseline and 42 months of age]
- Brain function (network topologies) [Time frame: at baseline and 42 months of age]
- Brain function (connection strengths) [Time frame: at baseline and 42 months of age]
- Cognitive flexibility [Time frame: at baseline and 42 months of age]
- Children development [Time frame: at baseline and 42 months of age]
- School readiness [Time frame: at 42 months of age]
- Children behavior (for toddlers) [Time frame: at baseline and 42 months of age]
- Curiosity [Time frame: at baseline and 42 months of age]
- Sleep quality [Time frame: at baseline and 42 months of age]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
China · 1 center
- Shanghai Children's Medical Center — Shanghai
Identifiers
NCT: NCT04916652 · 20.02.INF