Effect of Feeding Mode on Infant Growth and Cognitive Function

Mead Johnson Nutrition

Status: Completed

Conditions: Infant Nutrition

Treatments: Other: Cow's milk based formula; Other: Investigational nutrient-rich whey protein formula

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT02626143

6029

Details and patient eligibility

About

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.

Enrollment: 582 patients

Sex: All

Ages: Under 120 days old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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582 participants in 3 patient groups

Investigational nutrient-rich whey protein formula

Experimental group

Treatment:

Other: Investigational nutrient-rich whey protein formula

Cow's milk based formula

Active Comparator group

Treatment:

Other: Cow's milk based formula

Breast milk

No Intervention group