Growth and Tolerance of Young Infants Fed Infant Formulas

Abbott Nutrition209 enrolled

Overview

This is a randomized, multi-center, double blind, parallel study to compare growth and tolerance of healthy term infants fed either control or experimental infant formula.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

209

Conditions

Infant Newborn

Interventions

experimental infant formula with alternate protein sourceOTHER

experimental infant formula to be fed ad libitum

Infant formula powderOTHER

powdered infant formula to be fed ad libitum

Eligibility

Sex: ALLMax age: 8 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * healthy infant * full term * birth weight \> 2490 g * 0 to 8 days of age * parent/physician agree to not use medications affecting tolerance/growth * parent agrees to sole source feeding of study formula * parent agrees to not use vitamin/mineral supplements * parent has signed consent/HIPAA authorization Exclusion Criteria: * any maternal, fetal, or infant history affecting growth and tolerance * participation in any other study not preapproved by Abbott

Locations (12)

Norwich Pediatric Group, PC

Norwich, Connecticut, United States

SCORE Physician Alliance, LLC

St. Petersburg, Florida, United States

Northpoint Pedicatrics, LLC

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Weight gain

Time frame: 119 days

Secondary Outcomes

gastrointestinal tolerance

Stool characteristics, number of stools per day, and number of feedings associated with spit up or vomit

Time frame: 119 days

Anthropometric variables

Length gain per day and head circumference gain per day

Time frame: 119 days

Data from ClinicalTrials.gov

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