Growth and Tolerance of Young Infants Fed Infant Formulas

February 14, 2013 updated by: Abbott Nutrition
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

209

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Norwich, Connecticut, United States, 06360
        • Norwich Pediatric Group, PC
    • Florida
      • St. Petersburg, Florida, United States, 33710
        • SCORE Physician Alliance, LLC
    • Indiana
      • Indianapolis, Indiana, United States, 46038
        • Northpoint Pedicatrics, LLC
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Springs Medical Research, LLC
    • Nevada
      • Las Vegas, Nevada, United States, 89104
        • Clinical Research Center of Nevada
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Cary Pediatric Center
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Huber Heights, Ohio, United States, 45424
        • Ohio Pediatric Research Association, Inc.
      • Mayfield Heights, Ohio, United States, 44124
        • Institute of Clinical Research
      • Parma, Ohio, United States, 44129
        • The Cleveland Pediatric Research Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Sanford Clinic Family Medicine
    • Texas
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 1 week (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Infant formula, alternate protein source
Experimental infant formula with alternate protein source
Other: experimental infant formula with alternate protein source
experimental infant formula to be fed ad libitum
Active Comparator: Infant formula powder
Other: Infant formula powder
powdered infant formula to be fed ad libitum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight gain
Time Frame: 119 days
119 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastrointestinal tolerance
Time Frame: 119 days
Stool characteristics, number of stools per day, and number of feedings associated with spit up or vomit
119 days
Anthropometric variables
Time Frame: 119 days
Length gain per day and head circumference gain per day
119 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Marlene Borschel, PhD, Abbott Nutrition

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

June 16, 2011

First Submitted That Met QC Criteria

June 23, 2011

First Posted (Estimate)

June 27, 2011

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 14, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • AK92

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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