Growth and Tolerance of Healthy Term Infants Fed Cow's Milk-Based Infant Formulas

Mead Johnson Nutrition

Status: Withdrawn

Conditions: Growth

Treatments: Other: Cow's milk-based infant formula with added nutrients; Other: Marketed cow's milk-based infant formula

Study type: Interventional

Funder types: Industry

Identifiers

NCT02860026

3388-1

Details and patient eligibility

About

This clinical trial will compare the growth and tolerance of infants who consume an investigational cow's milk-based infant formula to those who consume a marketed cow's milk-based infant formula through approximately 4 months of age.

Sex: All

Ages: 10 to 14 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Singleton 10-14 days of age at randomization
• Term infant with birth weight of minimum of 2500 grams
• Solely formula fed
• Signed informed consent and protected health information

Exclusion criteria

• History of underlying metabolic or chronic disease, anemia, or immune compromise
• Feeding difficulties or formula intolerance

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Control

Active Comparator group

Description:

Marketed cow's milk-based infant formula

Treatment:

Other: Marketed cow's milk-based infant formula

Investigational

Experimental group

Description:

Cow's milk-based infant formula with added nutrients

Treatment:

Other: Cow's milk-based infant formula with added nutrients