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

Brain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04916652
• Other study ID #: 20.02.INF
• Status: Not yet recruiting
• Start date: November 2023
• Est. completion date: March 2025

Study information

• Verified date: October 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: Joyce Li
• Phone: +86 15810125435
• Email: joyce.li[@]rd.nestle.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 32 Months to 34 Months

Eligibility

Inclusion Criteria:

1. Written informed consent has been obtained from the parent/legally acceptable representative.

2. Full-term birth (more than 37 weeks and >2.5kg)

3. Children aged between 32 to 34 mo or 2.8 to 2.10 years at enrollment

4. Neurotypical development as assessed by interview

5. 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)].

6. 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:

1. Delayed birth ( > 41 weeks gestation) as reported in medical record

2. 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

3. History of neurological (e.g., head injury, epilepsy), psychiatric or developmental disorder in the toddler as assessed by interview

4. History of diagnosed neurological (e.g., head injury, epilepsy), psychiatric or developmental disorder in parents or siblings, as assessed by interview

5. 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

6. Multiple birth as reported in medical record

7. Complicated pregnancy (e.g., preeclampsia, gestational diabetes) as assessed by medical interview/ medical record

8. Abnormal screening laboratory values and studies considered to be clinically significant in the opinion of the Investigator (e.g., metabolic disease screening, neonatal bilirubin)

Related Conditions & MeSH terms

• Brain
• Growth & Development

Intervention

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).

Locations

Country	Name	City	State
China	Shanghai Children's Medical Center	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)	SAS Institute, Veeva Systems

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Anthropometry (weight in grams)	Weight in grams and corresponding weight-for-age Z-score according to the WHO growth standards	at baseline and 8 month after baseline
Other	Anthropometry (body length in centimeters)	Length in centimeters and corresponding length-for-age Z-score according to the WHO growth standards	at baseline and 8 month after baseline
Other	Anthropometry (weight-for-length)	Corresponding weight-for-length Z-score according to the WHO growth standards	at baseline and 8 month after baseline
Other	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 8 month after baseline
Other	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 8 month after baseline
Other	Gastrointestinal tolerance (for infants)	using validated Infant Gastrointestinal Symptom Questionnaire (IGSQ) for age 1.5-12 months	at baseline and 8 month after baseline
Other	Gastrointestinal tolerance (for toddlers)	using the Toddler Gut Comfort Questionnaire (TGCQ) for age 12-24 months	at baseline and 8 month after baseline
Other	Adverse Events (e.g., type, incidence, severity, seriousness)	standard AE reporting procedure	from enrollment until 36 months of age
Primary	Neural flexibility	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)	at baseline and 8 months after baseline
Secondary	Brain structure (brain regions volume)	Brain structure (brain regions volume) measured using MRI, including the hippocampal and frontal lobe volume (in cubic millimeter)	at baseline and 8 months after baseline
Secondary	Brain structure (cortical surface area)	Brain structure (cortical surface area) measured using MRI	at baseline and 8 months after baseline
Secondary	Brain structure (cortical thickness)	Brain structure (cortical thickness) measured using MRI	at baseline and 8 months after baseline
Secondary	Brain structure (myelination)	Brain structure (myelination) measured using MRI	at baseline and 8 months after baseline
Secondary	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 8 months after baseline
Secondary	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 8 months after baseline
Secondary	Children development	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	at baseline and 8 months after baseline
Secondary	Children attention	Using an established eye tracking protocol in Chinese pediatric population (using the Tobii TX300 eye tracker)	at baseline and 8 months after baseline
Secondary	Children behavior (for infants)	Using the Infant Behavior Questionnaire (IBQ) for age 3-12 months	at baseline and 8 months after baseline
Secondary	Children behavior (for toddlers)	Using the Early Childhood Behavioral Questionnaire (ECBQ) for age 13 - 36 months	at baseline and 8 months after baseline
Secondary	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 8 months after baseline
Secondary	Fecal microbiota composition	Measured via the shotgun metagenomics sequencing for species composition and functional pathways through stool samples collected	at baseline and 8 months after baseline
Secondary	Breast milk composition	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)	at baseline and 8 months after baseline
Secondary	Feeding practice	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
Secondary	Home environment	Using Home Environment questionnaire to collect information on household: siblings, and whether parents receive help on feeding the child.	at baseline and 8 months after baseline
Secondary	Cognitive flexibility	Using the Behavior Rating Inventory of Executive Function-Preschool Version (BRIEF-P) and the Dimensional Change Card Sort (DCCS) task	at 36 months of age