Clinical trial NCT04916652: A First-ever Research Collaboration to Characterize MRI Measured Neural Flexibility Development in Chinese Toddlers
Official title: A First-ever Research Collaboration to Characterize MRI Measured Neural Flexibility Development in Chinese Toddlers
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Growth & Development
Brain
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
Collaborators: name: SAS Institute
name: Veeva Systems
First posted: 2021-06-07
Enrollment: 60
Sex: ALL
Minimum age (years): 32
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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).

Brief 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).

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Neural flexibility
timeFrame: at baseline and 8 months after baseline
Secondary outcomes:
measure: Brain structure (brain regions volume)
timeFrame: at baseline and 8 months after baseline
measure: Brain structure (cortical surface area)
timeFrame: at baseline and 8 months after baseline
measure: Brain structure (cortical thickness)
timeFrame: at baseline and 8 months after baseline
measure: Brain structure (myelination)
timeFrame: at baseline and 8 months after baseline
measure: Brain function (network topologies)
timeFrame: at baseline and 8 months after baseline
measure: Brain function (connection strengths)
timeFrame: at baseline and 8 months after baseline
measure: Children development
timeFrame: at baseline and 8 months after baseline
measure: Children attention
timeFrame: at baseline and 8 months after baseline
measure: Children behavior (for infants)
timeFrame: at baseline and 8 months after baseline
measure: Children behavior (for toddlers)
timeFrame: at baseline and 8 months after baseline
measure: Sleep quality
timeFrame: at baseline and 8 months after baseline
measure: Fecal microbiota composition
timeFrame: at baseline and 8 months after baseline
measure: Breast milk composition
timeFrame: at baseline and 8 months after baseline
measure: Feeding practice
timeFrame: at baseline and 8 months after baseline
measure: Home environment
timeFrame: at baseline and 8 months after baseline
measure: Cognitive flexibility
timeFrame: at 36 months of age
Other outcomes:
measure: Anthropometry (weight in grams)
timeFrame: at baseline and 8 month after baseline
measure: Anthropometry (body length in centimeters)
timeFrame: at baseline and 8 month after baseline
measure: Anthropometry (weight-for-length)
timeFrame: at baseline and 8 month after baseline
measure: Anthropometry (head circumference in centimeters)
timeFrame: at baseline and 8 month after baseline
measure: Anthropometry (BMI)
timeFrame: at baseline and 8 month after baseline
measure: Gastrointestinal tolerance (for infants)
timeFrame: at baseline and 8 month after baseline
measure: Gastrointestinal tolerance (for toddlers)
timeFrame: at baseline and 8 month after baseline
measure: Adverse Events (e.g., type, incidence, severity, seriousness)
timeFrame: from enrollment until 36 months of age
Locations:
city: Shanghai
country: China
facility: Shanghai Children's Medical Center
state: Shanghai
Study officials:
affiliation: Shanghai Children's Medical Center
name: Fan Jiang
role: PRINCIPAL_INVESTIGATOR
References: