Growth of Infants Fed Hydrolysate Formulas

N/ACompletedNCT02006992

Abbott Nutrition195 enrolled

Overview

Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

195

Conditions

Growth and Tolerance

Interventions

RTF Infant FormulaOTHER

a RTF extensively hydrolyzed infant formula

Powder Infant FormulaOTHER

a powdered extensively hydrolyzed infant formula.

Eligibility

Sex: ALLMax age: 9 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Infants in good health. * Singleton, term birth with a gestational age of 37 to 42 weeks. * Birth weight of 2500 g (5 lb 8 oz) or greater. * Between 0 and 9 days of age at enrollment. * Not receiving vitamin or mineral supplements. Exclusion Criteria: \- Maternal, fetal or perinatal medical history with potential for adverse effects on growth or development.

Locations (8)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Dreyer Medical Center

Aurora, Illinois, United States

PediaResearch, LLC

Evansville, Indiana, United States

The University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

Weight

Time frame: Study day 1 to 112 days of age

Secondary Outcomes

Length

Time frame: Study day 1 to 112 days of age

Head Circumference

Time frame: Study day 1 to 112 days of age

Study Formula Intake

Time frame: Enrollment to 112 days of age

Incidence of Spit Up

Time frame: Enrollment to 112 days of age

Stool Pattern

Time frame: Enrollment to 112 days of age

Data from ClinicalTrials.gov

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