Growth and Tolerance of Cow Milk-Based Infant Formulas

Mead Johnson Nutrition405 enrolled

Overview

This clinical trial will assess growth, tolerance and adverse events of cow milk-based infant formulas in healthy, term infants.

Study Type

OBSERVATIONAL

Enrollment

405

Conditions

Body Weight

Eligibility

Sex: ALLMin age: 12 DaysMax age: 16 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Singleton, 12-16 days of age at randomization * Term infant with birth weight of minimum of 2500 g * Solely formula fed * Signed Informed Consent and Protected Health Information Exclusion Criteria: * History of underlying metabolic or chronic disease or immunocompromised * Acute infection * Feeding difficulties or formula intolerance

Locations (24)

Birmingham Pediatric Associates

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Body weight measured on calibrated infant scale at each study visit

Secondary Outcomes

Twenty-four hour recall of infant formula intake at each study visit

Medically-confirmed adverse events collected throughout the study period

Twenty-four hour recall of stool characteristics (number and consistency) and tolerance at each study visit

Parental Product Assessment Questionnaire completed at Study Visit 2

Assessment of physical properties of product and infant's reaction during consumption.

Body Length and Head Circumference measured at each study visit

Data from ClinicalTrials.gov

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