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NCT02626143 Clinical Trial

Effect of Feeding Mode on Infant Growth and Cognitive Function

Infant Nutrition Clinical Trial

Official title:
Effect of Feeding Mode on Infant Growth and Cognitive Function

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02626143
Other study ID # 6029
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 2016
Est. completion date March 2019

Study information
Verified date November 2020
Source Mead Johnson Nutrition
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 582
Est. completion date March 2019
Est. primary completion date February 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A to 120 Days
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Investigational nutrient-rich whey protein formula

• Cow's milk based formula

Locations
Country Name City State
Chile Instituto de Nutricion y Tecnologia de los Alimentos Santiago

Sponsors (2)
Lead Sponsor Collaborator
Mead Johnson Nutrition Instituto de Nutricion y Tecnologia de los Alimentos (INTA)

Country where clinical trial is conducted

Chile, 

Outcome
Type Measure Description Time frame Safety issue
Primary Body weight 24 months
Primary Auditory Event-related Potential 24 months
Primary Body length 24 months
Primary Head circumference 24 months
Secondary Dietary Intake 24 months
Secondary Medically confirmed adverse events 24 months
Secondary Body Composition: Air Displacement Plethysmography 6 months
Secondary Body Composition: Deuterium Dilution 12 and 24 months
Secondary Blood sample: Micronutrient status 24 months
Secondary Blood sample: Metabolic markers 24 months
Secondary Bayley Scales of Infant and Toddler Development 12 months
Secondary Sleep measures (Amount of time awake & asleep in a 7-day period) 24 months
Secondary Language development: Native3 Phoneme Repertory 12 months
Secondary Language development: Word Discovery 10 months
Secondary Language development: Rule Inference 10 months
Secondary Language development: MacArthur Communicative Development Inventory 24 months
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