Growth and Tolerance of Cow's Milk-Based Infant Formulas

Mead Johnson Nutrition373 enrolled

Overview

This clinical trial will evaluate the growth, tolerance, and iron status of infants who consume an investigational infant formula containing a nutrient-rich whey protein compared to a previously marketed infant formula.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

373

Conditions

Growth

Interventions

Previously marketed infant formulaOTHER

Previously marketed formula using a similar proteinOTHER

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 a minimum of 2500 grams * Solely formula fed * Signed Informed Consent and Protected Health Information Exclusion Criteria: * Anemia at time of birth * Current use of iron or iron-containing supplements * History of underlying metabolic or chronic disease or immunocompromised * Feeding difficulties or formula intolerance

Locations (22)

Birmingham Pediatric Associates

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Body weight measured at each study visit

Measurement collected with a calibrated infant scale

Time frame: 12 months

Secondary Outcomes

Body length measured at each study visit

Measurement collected with a standardized length board

Time frame: 12 months

Head circumference measured at each study visit

Measurement collected with a standardized measuring tape

Time frame: 12 months

Parental recall of study formula intake at each study visit

Time frame: 12 months

Parental recall of stool consistency measured at each study visit

Time frame: 12 months

Blood Collection

Composite measure of hemoglobin, hematocrit, ferritin, and c-reactive protein

Time frame: Once at 12 months

Medically-confirmed adverse events collected throughout the study period

Time frame: 12 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.