Preterm Infant Growth

November 3, 2014 updated by: Société des Produits Nestlé (SPN)

Growth of Preterm Infants Consuming Formula

The purpose of this study is to assess growth of preterm infants fed a test formula compared to a standard formula up to the first 4 months of corrected gestational age.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

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
    • California
      • Oakland, California, United States
        • Children's Hospital & Research Center
    • Illinois
      • Park Ridge, Illinois, United States
        • Advocate Lutheran Children's Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52241
        • University of Iowa
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Center for Human Nutrition
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Midatlantic Neonatology Associates, Inc
    • Ohio
      • Akron, Ohio, United States, 44308
        • Children's Hospital Medical Center of Akron
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Utah
      • Salt Lake City,, Utah, United States, 84108
        • University of Utah, Dept of Pediatrics
    • Virginia
      • Richmond, Virginia, United States, 23298
        • VCU Children's Medical Center

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 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Born AGA
  • Exclusively formula-fed
  • 28-34 weeks GA at birth
  • Intact GI tract, tolerating full oral feeds
  • Expected to be discharged from the hospital within a minimum of 24 hours, maximum of 5 days

Exclusion Criteria:

  • Severe respiratory disease defined as needing mechanical ventilation at discharge
  • Any significant systemic diseases that could affect growth. This includes cardiac, neurologic, or GI conditions.
  • Major congenital malformation, history of GI surgery, severe postnatal complications
  • Daily or routine diuretic use at time of discharge
  • Receiving more than 10% of daily kcals from food additives such as thickeners
  • Currently participating or having participated in another conflicting clinical trial.

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: Control
commercially available formula
Other: control infant formula
commercially available infant formula
Other Names:
  • commercially available infant formula fed to infants until 6 months corrected gestational age
Experimental: Test
test formula
Other: infant formula
test infant formula fed to infants until 6 months corrected gestational age
Other Names:
  • test infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth
Time Frame: 4 months
weight gain assessed monthly
4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
growth, tolerance, morbidity
Time Frame: 6 months
gains in length and head circumference assessed monthly, tolerance and morbidity throughout study
6 months
Total body bone mineral content and density and body composition, protein status, and metabolic markers
Time Frame: corrected term and 4 months
corrected term and 4 months

Collaborators and Investigators

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

Sponsor

Société des Produits Nestlé (SPN)

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

September 1, 2010

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 14, 2010

First Posted (Estimate)

July 15, 2010

Study Record Updates

Last Update Posted (Estimate)

November 4, 2014

Last Update Submitted That Met QC Criteria

November 3, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 09.02.US.INF

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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