- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04916652
A First-ever Research Collaboration to Characterize MRI Measured Neural Flexibility Development in Chinese Toddlers (MIND)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Joyce Li
- Phone Number: +86 15810125435
- Email: joyce.li@rd.nestle.com
Study Locations
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Shanghai
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Shanghai, Shanghai, China
- Shanghai Children's Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Written informed consent has been obtained from the parent/legally acceptable representative.
- Full-term birth (more than 37 weeks and >2.5kg)
- Children aged between 32 to 34 mo or 2.8 to 2.10 years at enrollment
- 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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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. |
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).
|
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. |
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neural flexibility
Time Frame: at baseline and 8 months after baseline
|
Neural flexibility is a quantitative measure of the frequency at which brain regions change their allegiance from one functional module to another during a given time period.
It will be measured by MRI at the brain regions implicated to be 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, frontal eye fields, and temporoparietal junction)
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at baseline and 8 months after baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Brain structure (brain regions volume)
Time Frame: at baseline and 8 months after baseline
|
Brain structure (brain regions volume) measured using MRI, including the hippocampal and frontal lobe volume (in cubic millimeter)
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at baseline and 8 months after baseline
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Brain structure (cortical surface area)
Time Frame: at baseline and 8 months after baseline
|
Brain structure (cortical surface area) measured using MRI
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at baseline and 8 months after baseline
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Brain structure (cortical thickness)
Time Frame: at baseline and 8 months after baseline
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Brain structure (cortical thickness) measured using MRI
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at baseline and 8 months after baseline
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Brain structure (myelination)
Time Frame: at baseline and 8 months after baseline
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Brain structure (myelination) measured using MRI
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at baseline and 8 months after baseline
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Brain function (network topologies)
Time Frame: at baseline and 8 months after baseline
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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
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at baseline and 8 months after baseline
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Brain function (connection strengths)
Time Frame: at baseline and 8 months after baseline
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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
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at baseline and 8 months after baseline
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Children development
Time Frame: at baseline and 8 months after baseline
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Using the Griffiths Mental Development Scales for China (GDS-C).
Gross and fine motor, personal-social-emotional, language and communication and learning development will be assessed
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at baseline and 8 months after baseline
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Children attention
Time Frame: at baseline and 8 months after baseline
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Using an established eye tracking protocol in Chinese pediatric population (using the Tobii TX300 eye tracker)
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at baseline and 8 months after baseline
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Children behavior (for infants)
Time Frame: at baseline and 8 months after baseline
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Using the Infant Behavior Questionnaire (IBQ) for age 3-12 months
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at baseline and 8 months after baseline
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Children behavior (for toddlers)
Time Frame: at baseline and 8 months after baseline
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Using the Early Childhood Behavioral Questionnaire (ECBQ) for age 13 - 36 months
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at baseline and 8 months after baseline
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Sleep quality
Time Frame: at baseline and 8 months after baseline
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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
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at baseline and 8 months after baseline
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Fecal microbiota composition
Time Frame: at baseline and 8 months after baseline
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Measured via the shotgun metagenomics sequencing for species composition and functional pathways through stool samples collected
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at baseline and 8 months after baseline
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Breast milk composition
Time Frame: at baseline and 8 months after baseline
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Breast milk composition (lipids, carbohydrates, proteins, minerals and vitamins) will be measured by the MIRIS analyzer through breast milk samples collected (only for breast-fed subjects)
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at baseline and 8 months after baseline
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Feeding practice
Time Frame: at baseline and 8 months after baseline
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Using validated Child Feeding Practice Questionnaire.
In addition, to complete the feeding and adverse events calendar monthly during home period
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at baseline and 8 months after baseline
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Cognitive flexibility
Time Frame: at 36 months of age
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Using the Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) and the Dimensional Change Card Sort (DCCS) task
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at 36 months of age
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Home environment
Time Frame: at baseline and 8 months after baseline
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Using Home Environment questionnaire to collect information on household: siblings, and whether parents receive help on feeding the child.
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at baseline and 8 months after baseline
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anthropometry (weight in grams)
Time Frame: at baseline and 8 month after baseline
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Weight in grams and corresponding weight-for-age Z-score according to the WHO growth standards
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at baseline and 8 month after baseline
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Anthropometry (body length in centimeters)
Time Frame: at baseline and 8 month after baseline
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Length in centimeters and corresponding length-for-age Z-score according to the WHO growth standards
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at baseline and 8 month after baseline
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Anthropometry (weight-for-length)
Time Frame: at baseline and 8 month after baseline
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Corresponding weight-for-length Z-score according to the WHO growth standards
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at baseline and 8 month after baseline
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Anthropometry (head circumference in centimeters)
Time Frame: at baseline and 8 month after baseline
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Head circumference in centimeters and corresponding head-circumference-for-age Z-score according to the WHO growth standards
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at baseline and 8 month after baseline
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Anthropometry (BMI)
Time Frame: at baseline and 8 month after baseline
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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
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at baseline and 8 month after baseline
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Gastrointestinal tolerance (for infants)
Time Frame: at baseline and 8 month after baseline
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using validated Infant Gastrointestinal Symptom Questionnaire (IGSQ) for age 1.5-12 months
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at baseline and 8 month after baseline
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Gastrointestinal tolerance (for toddlers)
Time Frame: at baseline and 8 month after baseline
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using the Toddler Gut Comfort Questionnaire (TGCQ) for age 12-24 months
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at baseline and 8 month after baseline
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Adverse Events (e.g., type, incidence, severity, seriousness)
Time Frame: from enrollment until 36 months of age
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standard AE reporting procedure
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from enrollment until 36 months of age
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Collaborators and Investigators
Investigators
- Principal Investigator: Fan Jiang, Shanghai Children's Medical Center
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 20.02.INF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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