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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| S-26 GOLD/ULTIMA GUM-fed group: | Parent(s) to continue feeding their child S-26 GOLD or ULTIMA GUM during the course of the study. We will collect information from parents on the S-26 GOLD/ ULTIMA GUM for a maximum of 2 months prior to the study start and during the course of the study. |
| |
| Cow's milk-fed group: | Parent(s) to continue feeding their child cow's milk during the course of the study. We will collect information from parents on the cow's milk consumed for a maximum of 2 months prior to the study start and during the course of the study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at baseline and 42 months after baseline |
| 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 | at baseline and 42 months of age |
| Measure | Description | Time Frame |
|---|---|---|
| Brain structure (brain regions volume) | Brain structure (brain regions volume) measured using MRI, including the hippocampal | at baseline and 42 months of age |
| Brain structure (cortical surface area) |
| Measure | Description | Time Frame |
|---|---|---|
| Gastrointestinal tolerance (for toddlers) | using the Toddler Gut Comfort Questionnaire (TGCQ) | at baseline and 42 months of age |
| Anthropometry (weight in grams) | Weight in grams and corresponding weight-for-age Z-score according to the WHO growth standards |
Inclusion Criteria:
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:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joyce Li | Contact | +86 15810125435 | joyce.li@rd.nestle.com |
| Name | Affiliation | Role |
|---|---|---|
| Fan Jiang | Shanghai Children's Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Children's Medical Center | Recruiting | Shanghai | Shanghai Municipality | China |
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Brain structure (cortical surface area) measured using MRI
| at baseline and 42 months of age |
| Brain structure (cortical thickness) | Brain structure (cortical thickness) measured using MRI | at baseline and 42 months of age |
| Brain structure (myelination) | Brain structure (myelination) measured using MRI | at baseline and 42 months of age |
| Brain function (network topologies) | Brain functional network topologies of the nine commonly assessed brain functional networks, including the primary visual, secondary visual, visual association, motosensory, default mode, frontoparietal, medial frontal, subcortical and cerebellum networks using MRI | at baseline and 42 months of age |
| Brain function (connection strengths) | Brain functional connection strengths of the nine commonly assessed brain functional networks, including the primary visual, secondary visual, visual association, motosensory, default mode, frontoparietal, medial frontal, subcortical and cerebellum networks using MRI | at baseline and 42 months of age |
| Cognitive flexibility | Using the Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) parent-completed questionnaire | at baseline and 42 months of age |
| Children development | Verbal Comprehension, Visual Spatial, Working Memory, and IQ using Wechsler Preschool and Primary Scale of Intelligence (WPPSI-IV) | at baseline and 42 months of age |
| School readiness | Using Early Human Capability Index (eHCI) | at 42 months of age |
| Children behavior (for toddlers) | Using the Early Childhood Behavioral Questionnaire (ECBQ) | at baseline and 42 months of age |
| Curiosity | Using the Curiosity Questionnaire | at baseline and 42 months of age |
| Sleep quality | Sleep quality, duration and efficiency (total sleep time / duration of sleep episode *100) computed using the Brief Infant Sleep Questionnaire (BISQ). In addition, an actigraphy in combination with a sleep diary will be used during home period and their relationship will indicate the sleep quality | at baseline and 42 months of age |
| Home environment | Using validated Child Feeding Practice Questionnaire. In addition, to complete the feeding and adverse events calendar monthly during home period | at baseline and 8 months after baseline |
| Feeding practice | Using the Early Feeding Practice Questionnaire. In addition, the feeding and adverse events calendar monthly during home period | at baseline and 42 months of age |
| Fecal microbiota composition | Measured via the shotgun metagenomics sequencing for species composition and functional pathways through stool samples collected | at baseline and 42 months of age |
| Cognitive flexibility | Using the Dimensional Change Card Sort (DCCS) task | at baseline and 42 months of age |
| at baseline and 42 months of age |
| Anthropometry (body length in centimeters) | Length in centimeters and corresponding length-for-age Z-score according to the WHO growth standards | at baseline and 42 months of age |
| Anthropometry (weight-for-length) | Corresponding weight-for-length Z-score according to the WHO growth standards | at baseline and 42 months of age |
| Anthropometry (head circumference in centimeters) | Head circumference in centimeters and corresponding head-circumference-for-age Z-score according to the WHO growth standards | at baseline and 42 months of age |
| Anthropometry (BMI) | Weight and height will be combined to report the BMI (kg/m2) and corresponding BMI-for-age Z-score according to the WHO growth standards | at baseline and 42 months of age |
| Adverse Events (e.g., type, incidence, severity, seriousness) | standard AE reporting procedure | from enrollment until 42.5 months of age |