Growth and Tolerance of Young Infants Fed Infant Formulas

Phase 3

Completed

• Conditions: Infant Newborn
• Interventions: Other: experimental infant formula with alternate protein source; Other: Infant formula powder

• Registration Number: NCT01380886
• Lead Sponsor: Abbott Nutrition

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-16
• Study First Submitted QC: 2011-06-23
• Study First Posted: 2011-06-27
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-14
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 209

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Infant formula, alternate protein source	experimental infant formula with alternate protein source	Experimental infant formula with alternate protein source
Infant formula powder	Infant formula powder	Infant formula powder

Primary Outcome Measures

Name	Time	Method
Weight gain	119 days

Secondary Outcome Measures

Name	Time	Method
gastrointestinal tolerance	119 days	Stool characteristics, number of stools per day, and number of feedings associated with spit up or vomit
Anthropometric variables	119 days	Length gain per day and head circumference gain per day

Trial Locations

Locations (12)

DCOL Center for Clinical Research; 🇺🇸 Longview, Texas, United States

Sanford Clinic Family Medicine; 🇺🇸 Sioux Falls, South Dakota, United States

SCORE Physician Alliance, LLC; 🇺🇸 St. Petersburg, Florida, United States

Northpoint Pedicatrics, LLC; 🇺🇸 Indianapolis, Indiana, United States

Ohio Pediatric Research Association, INC.; 🇺🇸 Huber Heights, Ohio, United States

Norwich Pediatric Group, PC; 🇺🇸 Norwich, Connecticut, United States

Springs Medical Research, LLC; 🇺🇸 Owensboro, Kentucky, United States

Institute of Clinical Research; 🇺🇸 Mayfield Heights, Ohio, United States

The Cleveland Pediatric Research Center; 🇺🇸 Parma, Ohio, United States

MetroHealth Medical Center; 🇺🇸 Cleveland, Ohio, United States

Clinical Research Center of Nevada; 🇺🇸 Las Vegas, Nevada, United States

Cary Pediatric Center; 🇺🇸 Cary, North Carolina, United States