Growth of Infants Fed Hydrolysate Formulas

December 11, 2013 updated by: Abbott Nutrition
Effects on weight and weight gain will be monitored in healthy term infants fed assigned infant formulas.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

195

Phase

  • Not Applicable

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
        • Arkansas Children's Hospital
    • Illinois
      • Aurora, Illinois, United States
        • Dreyer Medical Center
    • Indiana
      • Evansville, Indiana, United States
        • PediaResearch, LLC
    • Iowa
      • Iowa City, Iowa, United States
        • The University of Iowa Hospitals and Clinics
    • Kentucky
      • Bardstown, Kentucky, United States
        • Kentucky Pediatric Research
    • Missouri
      • Kansas City, Missouri, United States
        • Children's Mercy Hospital
    • North Carolina
      • Chapel Hill, North Carolina, United States
        • NC Children's & Young Adults' Clinical Research Foundation
    • Pennsylvania
      • Sellersville, Pennsylvania, United States
        • GrandView Medical 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:

  • 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 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

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RTF Infant Formula 1
a ready to feed (RTF) extensively hydrolyzed infant formula fed ad lib.
Other: RTF Infant Formula
a RTF extensively hydrolyzed infant formula
Experimental: Powder Infant Formula 2
a powdered extensively hydrolyzed infant formula fed ad lib.
Other: Powder Infant Formula
a powdered extensively hydrolyzed infant formula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Weight
Time Frame: Study day 1 to 112 days of age
Study day 1 to 112 days of age

Secondary Outcome Measures

Outcome Measure
Time Frame
Length
Time Frame: Study day 1 to 112 days of age
Study day 1 to 112 days of age
Head Circumference
Time Frame: Study day 1 to 112 days of age
Study day 1 to 112 days of age
Study Formula Intake
Time Frame: Enrollment to 112 days of age
Enrollment to 112 days of age
Incidence of Spit Up
Time Frame: Enrollment to 112 days of age
Enrollment to 112 days of age
Stool Pattern
Time Frame: Enrollment to 112 days of age
Enrollment to 112 days of age

Collaborators and Investigators

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

Sponsor

Abbott Nutrition

Investigators

  • Study Chair: Marlene Borschel, RD, 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

March 1, 2000

Primary Completion (Actual)

November 1, 2000

Study Completion (Actual)

November 1, 2000

Study Registration Dates

First Submitted

December 5, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 10, 2013

Study Record Updates

Last Update Posted (Estimate)

December 12, 2013

Last Update Submitted That Met QC Criteria

December 11, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • AJ57

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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