Effect of Feeding Mode on Infant Growth and Cognitive Function

Not Applicable

Completed

• Conditions: Infant Nutrition
• Interventions: Other: Investigational nutrient-rich whey protein formula; Other: Cow's milk based formula

• Registration Number: NCT02626143
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

This study is intended to compare growth, nutritional status, and brain development in children fed an Investigational cow's milk based formula containing a nutrient-rich whey protein, a standard cow's milk based formula, or fed exclusively breast milk.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-03
• Study First Submitted QC: 2015-12-07
• Study First Posted: 2015-12-10
• Study Start: 2016-02
• Primary Completion: 2019-02
• Study Completion: 2019-03
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-10
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 582

Inclusion Criteria

• Singleton, 0-120 days of age at study entry
• Term infant with birth weight of 2500 to 4500 grams
• Exclusively feed infant formula or exclusively feeding breast milk
• Signed informed consent

Exclusion Criteria

• History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised.
• Feeding difficulties or formula intolerance
• Receiving complementary feedings

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational nutrient-rich whey protein formula	Investigational nutrient-rich whey protein formula	-
Cow's milk based formula	Cow's milk based formula	-

Primary Outcome Measures

Name	Time	Method
Auditory Event-related Potential	24 months
Body length	24 months
Body weight	24 months
Head circumference	24 months

Secondary Outcome Measures

Name	Time	Method
Medically confirmed adverse events	24 months
Body Composition: Deuterium Dilution	12 and 24 months
Language development: Rule Inference	10 months
Language development: Word Discovery	10 months
Dietary Intake	24 months
Blood sample: Metabolic markers	24 months
Blood sample: Micronutrient status	24 months
Language development: Native3 Phoneme Repertory	12 months
Body Composition: Air Displacement Plethysmography	6 months
Bayley Scales of Infant and Toddler Development	12 months
Sleep measures (Amount of time awake & asleep in a 7-day period)	24 months
Language development: MacArthur Communicative Development Inventory	24 months

Trial Locations

Locations (1)

Instituto de Nutricion y Tecnologia de los Alimentos; 🇨🇱 Santiago, Chile