Tolerance and Development of Healthy, Term Infants

April 24, 2009 updated by: Abbott Nutrition

Pilot Tolerance and Bone Status of Healthy, Term Infants Fed Infant Formulas

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 2

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
    • Nebraska
      • Lincoln, Nebraska, United States, 68505
        • Midwest Children's Health Research Institute
    • Texas
      • Houston, Texas, United States, 77030
        • Children's Nutrition Research Center, Baylor College of Medicine

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

1 day to 1 week (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

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: Protein formula
Feed as per HCP direction
Other: Alternate protein infant formula
Feed as per HCP directions
Active Comparator: Standard infant formula
Feed as per HCP instructions
Other: Standard infant formula
Feed as per HCP directions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean rank stool consistency at 14 days of age
Time Frame: 14 days of age
14 days of age

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood chemistries, bone mineral content, percent of feedings with spit-up or vomit associated with feeding
Time Frame: 14 days
14 days

Collaborators and Investigators

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

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Marlene W 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

April 1, 2007

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

April 23, 2007

First Submitted That Met QC Criteria

April 24, 2007

First Posted (Estimate)

April 25, 2007

Study Record Updates

Last Update Posted (Estimate)

April 27, 2009

Last Update Submitted That Met QC Criteria

April 24, 2009

Last Verified

June 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AK44

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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