Growth and Tolerance of Hypoallergenic Formulas

Mead Johnson Nutrition511 enrolled

Overview

This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.

Study Type

OBSERVATIONAL

Enrollment

511

Conditions

Growth of Term Infants

Interventions

Infant formulaOTHER

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 a minimum of 2500 grams * Solely formula fed * Signed Informed Consent and Protected Health Information Exclusion Criteria: * History of underlying metabolic or chronic disease or immunocompromised * Feeding difficulties or formula intolerance

Locations (24)

Birmingham Pediatric Associates

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Body weight measured at each study visit

Time frame: 3.5 months

Secondary Outcomes

Recall of infant formula intake at each study visit

Time frame: 3.5 months

Body Length and Head Circumference measured at each study visit

Time frame: 3.5 months

Recall of stool characteristics and tolerance at each study visit

Time frame: 3.5 months

Medically-confirmed adverse events collected throughout the study period

Time frame: 3.5 months

Parental Product Assessment Questionnaire completed at Study Visit 2

Time frame: once

Data from ClinicalTrials.gov

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