About this trial
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).
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Healthy normal developing Chinese toddlers; minimum number of subjects with successful MRI scans at enrolment and age 42 months: N=60 (≈ 30 fed on S-26 GOLD/ ULTIMA growing-up milk (GUM) and ≈30 fed on cows' milk) with key inclusion as daily consumption of the S-26 GUM or cow's milk for the last 60 days (2 mo).
Trial design
Case-control
Prospective
Treatments tested in this trial
MRI
RadiationMRI 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).
Treatment groups
Trial outcomes
Primary outcomes
Neural flexibility
MRI-derived neural flexibility associated with cognitive flexibility (including anterior cingulate cortex, dorsolateral prefrontal cortex, ventrolateral prefrontal cortex, anterior insula, interior frontal junction, superior parietal lobule, precuneus, intraparietal sulcus, and temporoparietal junction)
Global Executive Composite (GEC) score
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
Secondary outcomes
Brain structure (brain regions volume)
Brain structure (brain regions volume) measured using MRI, including the hippocampal
Brain structure (cortical surface area)
Brain structure (cortical surface area) measured using MRI
Brain structure (cortical thickness)
Brain structure (cortical thickness) measured using MRI
Brain structure (myelination)
Brain structure (myelination) measured using MRI
Other outcomes
Gastrointestinal tolerance (for toddlers)
using the Toddler Gut Comfort Questionnaire (TGCQ)
Anthropometry (weight in grams)
Weight in grams and corresponding weight-for-age Z-score according to the WHO growth standards
Anthropometry (body length in centimeters)
Length in centimeters and corresponding length-for-age Z-score according to the WHO growth standards
Anthropometry (weight-for-length)
Corresponding weight-for-length Z-score according to the WHO growth standards
Sponsors and contacts
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