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

Mead Johnson Nutrition

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Conditions

Growth

Interventions

Marketed cow's milk-based infant formulaOTHER

Cow's milk-based infant formula with added nutrientsOTHER

Eligibility

Sex: ALLMin age: 10 DaysMax age: 14 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (17)

Birmingham Pediatric Associates

Birmingham, Alabama, United States

Southeastern Pediatric Associates

Dothan, Alabama, United States

Outcomes

Primary Outcomes

Rate of body weight gain from 14 to 120 days of age

Time frame: 3.5 months

Secondary Outcomes

Recall of infant formula at each study visit

Time frame: Up to 3.5 months

Body length measured at each study visit

Time frame: Up to 3.5 months

Recall of stool characteristics questionnaire measured at each study visit

Time frame: Up to 3.5 months

Head circumference measured at each study visit

Time frame: Up to 3.5 months

Recall of gastrointestinal tolerance questionnaire at each study visit

Time frame: Up to 3.5 months

Medically confirmed adverse events collected throughout the study period

Time frame: Up to 3.5 months

Data from ClinicalTrials.gov

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