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Preterm Infant Growth

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01162798
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : November 4, 2014
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Growth Development Infant Other: infant formula Other: control infant formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: Growth of Preterm Infants Consuming Formula
Study Start Date : September 2010
Actual Primary Completion Date : October 2013
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Control
commercially available formula
Other: control infant formula
commercially available infant formula
Other Name: 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 Name: test infant formula

Primary Outcome Measures :
  1. Growth [ Time Frame: 4 months ]
    weight gain assessed monthly

Secondary Outcome Measures :
  1. growth, tolerance, morbidity [ Time Frame: 6 months ]
    gains in length and head circumference assessed monthly, tolerance and morbidity throughout study

  2. Total body bone mineral content and density and body composition, protein status, and metabolic markers [ Time Frame: corrected term and 4 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01162798

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United States, California
Children's Hospital & Research Center
Oakland, California, United States
United States, Illinois
Advocate Lutheran Children's Hospital
Park Ridge, Illinois, United States
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52241
United States, Nebraska
Center for Human Nutrition
Omaha, Nebraska, United States, 68105
United States, New Jersey
Midatlantic Neonatology Associates, Inc
Morristown, New Jersey, United States, 07962
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Utah
University of Utah, Dept of Pediatrics
Salt Lake City,, Utah, United States, 84108
United States, Virginia
VCU Children's Medical Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
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Principal Investigator: Ekhard Ziegler, MD University of Iowa
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Responsible Party: Nestlé Identifier: NCT01162798    
Other Study ID Numbers: 09.02.US.INF
First Posted: July 15, 2010    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014
Keywords provided by Nestlé:
infant formula
premature infants
Growth and Development