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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age32-34
SponsorSociété des Produits Nestlé (SPN)

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • MRI

    Radiation

    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).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: S-26 GOLD/ULTIMA GUM-fed group:1 intervention
Group B: Cow's milk-fed group:1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
at baseline and 42 months after baseline
2

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

Time frame
at baseline and 42 months of age

Secondary outcomes

1

Brain structure (brain regions volume)

Brain structure (brain regions volume) measured using MRI, including the hippocampal

Time frame
at baseline and 42 months of age
2

Brain structure (cortical surface area)

Brain structure (cortical surface area) measured using MRI

Time frame
at baseline and 42 months of age
3

Brain structure (cortical thickness)

Brain structure (cortical thickness) measured using MRI

Time frame
at baseline and 42 months of age
4

Brain structure (myelination)

Brain structure (myelination) measured using MRI

Time frame
at baseline and 42 months of age

Other outcomes

1

Gastrointestinal tolerance (for toddlers)

using the Toddler Gut Comfort Questionnaire (TGCQ)

Time frame
at baseline and 42 months of age
2

Anthropometry (weight in grams)

Weight in grams and corresponding weight-for-age Z-score according to the WHO growth standards

Time frame
at baseline and 42 months of age
3

Anthropometry (body length in centimeters)

Length in centimeters and corresponding length-for-age Z-score according to the WHO growth standards

Time frame
at baseline and 42 months of age
4

Anthropometry (weight-for-length)

Corresponding weight-for-length Z-score according to the WHO growth standards

Time frame
at baseline and 42 months of age

Sponsors and contacts

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