The Effect of Feeding Infant Formula With Enriched Protein Fractions in the US

Not Applicable

Terminated

• Conditions: Declarative Memory
• Interventions: Other: Cow milk-based infant formula with enriched protein fractions; Other: Cow's milk-based infant formula

• Registration Number: NCT02433600
• Lead Sponsor: Mead Johnson Nutrition

Brief Summary

This study is intended to measure declarative or stored memory and behavior between infants who consume one of two infant formulas through approximately one year of age.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-04-27
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-05-05
• Study Start: 2015-08
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

• Singleton, 0-90 days of age at randomization
• Term infant with birth weight of a minimum of 2500 grams
• Receiving at least 75% of the recommended caloric intake from cow's milk-based infant formula
• Parent or legally authorized representative attending study visits reads, understands, and speaks English
• Signed Informed Consent and Protected Health Information authorization

Exclusion Criteria

• History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
• Feeding difficulties or formula intolerance
• Infant born small for gestational age
• Infant born from a mother who was diabetic at childbirth
• History of seizures or neurological disorders or infant with known head/brain disease/injury

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cow milk-based infant formula with enriched protein fractions	Cow milk-based infant formula with enriched protein fractions	-
Cow's milk-based infant formula	Cow's milk-based infant formula	-

Primary Outcome Measures

Name	Time	Method
Sequence Recall using 3-dimensional props	365 days of age

Secondary Outcome Measures

Name	Time	Method
Achieved Weight	52 weeks
Electroencephalogram response to stimuli	180 days of age
Bayley Scales of Infant and Toddler Development, Third Edition	365 days of age
Achieved Head Circumference	52 weeks
Sequence Recall using 3-dimensional props	300 days of age
Infant Behavior Questionnaire Revised, Short	240 days of age
Achieved Length	52 weeks
Formula Intake	52 weeks
Medically-confirmed Adverse Events	52 weeks
MacArthur-Bates Communication Development Inventory	365 days of age

Trial Locations

Locations (1)

University or North Carolina Nutrition Research Instutite; 🇺🇸 Kannapolis, North Carolina, United States