The Effect of Feeding Infant Formula With Enriched Protein Fractions

Mead Johnson Nutrition3 sites in 1 country451 target enrollmentNovember 2014

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 2014

End Date

May 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Mead Johnson Nutrition

Responsible Party

Sponsor

•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

Infant cognitive development

Time Frame: At 12 months of age

Cognitive Scale of Bayley-III is used as the assessment tool.

Infant cognitive development(At 18 months of age)
Infant language and motor skills(At 4, 6, 9, 12 and 18 months of age)
Infant acquisition of social and emotional milestones and adaptive development(At 4, 6, 9, 12 and 18 months of age)
Infant temperament(At 12 and 18 months of age)
Infant attention capabilities(At 12 and 18 months of age)
Physical development(At 14, 30, 42, 60, 90, 120, 180, 275, 365, and 545 days of age)
Stool characteristics(At 14, 30, 42, 60, 90, 120, 180, 275 and 365 days of age)
Formula intake(At 30, 42, 60, 90, 120, 180, 275 and 365 days of age)
Fecal microbiome and metabolome profile(Average of 14 days of age and 120 days of age)
Medically-confirmed Adverse Events(Up to 19 months of age)