Tolerance and Development of Healthy, Term Infants

Abbott Nutrition115 enrolled

Overview

To compare the tolerance and early bone status of healthy, term infants fed formulas during the first three months of life.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

115

Conditions

Healthy

Interventions

Alternate protein infant formulaOTHER

Feed as per HCP directions

Standard infant formulaOTHER

Feed as per HCP directions

Eligibility

Sex: ALLMin age: 1 DayMax age: 8 DaysHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy term infants; * Age 0-8 days of age; * Exclusively formula fed; * No use of vitamin/mineral supplements. Exclusion Criteria: * Maternal, fetal or perinatal medical history thought to have potential for negative effects on tolerance, growth or development.

Locations (2)

Midwest Children's Health Research Institute

Lincoln, Nebraska, United States

Children's Nutrition Research Center, Baylor College of Medicine

Houston, Texas, United States

Outcomes

Primary Outcomes

Mean rank stool consistency at 14 days of age

Time frame: 14 days of age

Secondary Outcomes

Blood chemistries, bone mineral content, percent of feedings with spit-up or vomit associated with feeding

Time frame: 14 days

Data from ClinicalTrials.gov

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