Growth of Infants Fed an Elemental Medical Food

October 2, 2012 updated by: Abbott Nutrition
Effects on weight will be monitored in healthy infant subjects consuming assigned infant formulas.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

213

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
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • T&W Research
    • Iowa
      • Iowa City, Iowa, United States, 52242-1083
        • University of Iowa

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:

  • Singleton, healthy infant
  • Gestational age of 37 to 42 weeks
  • Birth weight of 2500 grams or greater
  • Age between birth and 9 days of age
  • Parents agree to not administer mineral or vitamin supplements during the study period
  • Parents agree to feed study formula exclusively for the duration of the study

Exclusion Criteria:

  • Maternal, fetal or perinatal history which may have adverse effects on growth
  • Multiple birth

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
Active Comparator: Control Study Formula
protein hydrolysate formula
Other: Control Study Formula
feed as lib
Other Names:
  • Nutramigen
  • protein hydrolysate formula
Experimental: Experimental Study Formula
free-amino acid-based medical food
Other: Experimental Study Formula
feed as lib
Other Names:
  • EleCare
  • free-amino acid-based medical food

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: 14 days of age to 112 days of age
weight gain during the study period
14 days of age to 112 days of age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric Measurements
Time Frame: 14 days of age to 112 days of age
length, head circumference, and length gain
14 days of age to 112 days of age
GI Tolerance
Time Frame: At visits 14 and 28
daily stool number, stool consistency, formula intake
At visits 14 and 28
Lab Measurement
Time Frame: At 112 day visit
serum albumin
At 112 day visit

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, RD, Abbott Nutrition

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 1999

Primary Completion (Actual)

December 1, 2000

Study Completion (Actual)

December 1, 2000

Study Registration Dates

First Submitted

October 2, 2012

First Submitted That Met QC Criteria

October 2, 2012

First Posted (Estimate)

October 3, 2012

Study Record Updates

Last Update Posted (Estimate)

October 3, 2012

Last Update Submitted That Met QC Criteria

October 2, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Other Study ID Numbers

  • AH73

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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