Cognitive Ability, General
Conditions
Brief summary
This study is intended to evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
Detailed description
To evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
Interventions
DIETARY_SUPPLEMENTEnriched Protein Fractions
Enriched protein fractions
DIETARY_SUPPLEMENTProtein Fractions
Protein fractions
Sponsors
Shanghai Children's Medical Center
Mead Johnson Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
10 Days to 14 Days
Healthy volunteers
Yes
Inclusion criteria
* 10-14 days of age * Exclusively formula-fed * Singleton birth * Gestational age of 37-42 weeks * Birth weight of 2500g to 4000g * Signed Informed Consent Form
Exclusion criteria
* History of underlying metabolic or chronic disease * Congenital malformation * Condition which is likely to interfere with food ingestion, normal growth, development and evaluation * Evidence of feeding difficulties or intolerance * Immunocompromised * Head/brain disease/injury
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Infant cognitive development | At 12 months of age | Cognitive Scale of Bayley-III is used as the assessment tool. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infant language and motor skills | At 4, 6, 9, 12 and 18 months of age | Ages and Stages Questionnaire, MacArthur-Bates Communicative Development Index, Language Scale and Motor Scale of Bayley-III are used as the assessment tool. |
| Infant acquisition of social and emotional milestones and adaptive development | At 4, 6, 9, 12 and 18 months of age | Ages and Stages Questionnaire, social-emotional scale and adaptive behavior scale of Bayley-III are used as assessment tool. |
| Infant temperament | At 12 and 18 months of age | Carey Scale is used as assessment tool. |
| Infant attention capabilities | At 12 and 18 months of age | Single Object Attention and Free Play Tasks is used as assessment tool. |
| Infant cognitive development | At 18 months of age | Cognitive Scale of Bayley-III is used as the assessment tool. |
| Stool characteristics | At 14, 30, 42, 60, 90, 120, 180, 275 and 365 days of age | According to the recall of parents during the last 24 hours. |
| Formula intake | At 30, 42, 60, 90, 120, 180, 275 and 365 days of age | According to the recall of parents during the last 24 hours. |
| Fecal microbiome and metabolome profile | Average of 14 days of age and 120 days of age | Fecal microbiome analysis is done at average of 14 days and 120 days of age. While metabolome profile analysis is done at only average of 120 days of age. |
| Medically-confirmed Adverse Events | Up to 19 months of age | — |
| Physical development | At 14, 30, 42, 60, 90, 120, 180, 275, 365, and 545 days of age | Body weight, length and head circumference are measured. |
Countries
China
Outcome results
None listed