This study is intended to evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
To evaluate the nutritive effects of study formulas on growth and cognitive outcomes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
451
Enriched protein fractions
Protein fractions
Fuyang Fifth People's Hospital
Fuyang, Anhui, China
Fuyang Maternal and Child Health Institute
Fuyang, Anhui, China
Yinquan Maternal and Child Health Institute
Fuyang, Anhui, China
Infant cognitive development
Cognitive Scale of Bayley-III is used as the assessment tool.
Time frame: At 12 months of age
Infant cognitive development
Cognitive Scale of Bayley-III is used as the assessment tool.
Time frame: At 18 months of age
Infant language and motor skills
Ages and Stages Questionnaire, MacArthur-Bates Communicative Development Index, Language Scale and Motor Scale of Bayley-III are used as the assessment tool.
Time frame: At 4, 6, 9, 12 and 18 months of age
Infant acquisition of social and emotional milestones and adaptive development
Ages and Stages Questionnaire, social-emotional scale and adaptive behavior scale of Bayley-III are used as assessment tool.
Time frame: At 4, 6, 9, 12 and 18 months of age
Infant temperament
Carey Scale is used as assessment tool.
Time frame: At 12 and 18 months of age
Infant attention capabilities
Single Object Attention and Free Play Tasks is used as assessment tool.
Time frame: At 12 and 18 months of age
Physical development
Body weight, length and head circumference are measured.
Time frame: At 14, 30, 42, 60, 90, 120, 180, 275, 365, and 545 days of age
Stool characteristics
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
According to the recall of parents during the last 24 hours.
Time frame: At 14, 30, 42, 60, 90, 120, 180, 275 and 365 days of age
Formula intake
According to the recall of parents during the last 24 hours.
Time frame: At 30, 42, 60, 90, 120, 180, 275 and 365 days of age
Fecal microbiome and metabolome profile
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.
Time frame: Average of 14 days of age and 120 days of age
Medically-confirmed Adverse Events
Time frame: Up to 19 months of age