Growth of Infants Fed Hydrolysate Formulas

Not Applicable

Completed

• Conditions: Growth and Tolerance
• Interventions: Other: RTF Infant Formula; Other: Powder Infant Formula

• Registration Number: NCT02006992
• Lead Sponsor: Abbott Nutrition

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-03
• Primary Completion: 2000-11
• Study Completion: 2000-11
• Status Verified: 2013-12
• Study First Submitted: 2013-12-05
• Study First Submitted QC: 2013-12-05
• Study First Posted: 2013-12-10
• Last Update Submitted: 2013-12-11
• Last Update Posted: 2013-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 195

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RTF Infant Formula 1	RTF Infant Formula	a ready to feed (RTF) extensively hydrolyzed infant formula fed ad lib.
Powder Infant Formula 2	Powder Infant Formula	a powdered extensively hydrolyzed infant formula fed ad lib.

Primary Outcome Measures

Name	Time	Method
Weight	Study day 1 to 112 days of age

Secondary Outcome Measures

Name	Time	Method
Length	Study day 1 to 112 days of age
Head Circumference	Study day 1 to 112 days of age
Study Formula Intake	Enrollment to 112 days of age
Incidence of Spit Up	Enrollment to 112 days of age
Stool Pattern	Enrollment to 112 days of age

Trial Locations

Locations (8)

Arkansas Children's Hospital; 🇺🇸 Little Rock, Arkansas, United States

Dreyer Medical Center; 🇺🇸 Aurora, Illinois, United States

PediaResearch, LLC; 🇺🇸 Evansville, Indiana, United States

Children's Mercy Hospital; 🇺🇸 Kansas City, Missouri, United States

Kentucky Pediatric Research; 🇺🇸 Bardstown, Kentucky, United States

The University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States

GrandView Medical Research; 🇺🇸 Sellersville, Pennsylvania, United States

NC Children's & Young Adults' Clinical Research Foundation; 🇺🇸 Chapel Hill, North Carolina, United States