The Effects on Growth and Tolerance of a Routine Infant Formula Fed to Term Infants

Mead Johnson Nutrition315 enrolled

Overview

This clinical trial will evaluate an investigational infant formula with an alternate source of DHA to determine if it provides normal growth and if it is well tolerated by term infants as compared to a marketed routine infant formula.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

315

Conditions

Growth of Term Infants

Interventions

Control: Marketed routine infant formulaOTHER

An investigational infant formula containing an alternate source of DHAOTHER

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: * 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

Time frame: 3.5 Months

Secondary Outcomes

Recall of infant formula intake at each study visit

Time frame: 3.5 months

Body length measured at each study visit

Time frame: 3.5 months

Recall of stool consistency measured at each study visit

Time frame: 3.5 months

Medically-confirmed adverse events collected throughout the study period

Time frame: 3.5 months

Head circumference measured at each study visit

Time frame: 3.5 months

Recall of gastrointestinal tolerance measured at each study visit

Time frame: 3.5 months

Blood Collection

Blood Collection from a subset of participants to measure levels of fatty acids such as docosahexaenoic acid (DHA) and arachidonic acid (ARA).

Time frame: Once at 120 days of age

Data from ClinicalTrials.gov

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