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Preterm Infant Growth

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Nestlé.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Nestlé
ClinicalTrials.gov Identifier:
NCT01162798
First received: July 13, 2010
Last updated: August 15, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention
Growth
Development
Infant
 Other: infant formula
Other: control infant formula

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: Growth of Preterm Infants Consuming Formula

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nestlé:

Primary Outcome Measures:
  • Growth [ Time Frame: 4 months ] [ Designated as safety issue: No ]
    weight gain assessed monthly


Secondary Outcome Measures:
  • growth, tolerance, morbidity [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    gains in length and head circumference assessed monthly, tolerance and morbidity throughout study

  • Total body bone mineral content and density and body composition, protein status, and metabolic markers [ Time Frame: corrected term and 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2010
Estimated Study Completion Date: September 2011
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162798

Contacts
Contact: Ekhard Ziegler, MD (319) 335-4570 ekhard-ziegler@uiowa.edu

Locations
United States, California
Children's Hospital & Research Center Recruiting
Oakland, California, United States
Contact: Durand            
Principal Investigator: D Durand            
United States, Illinois
Advocate Lutheran Children's Hospital Recruiting
Park Ridge, Illinois, United States
Contact: Puppala, MD            
Principal Investigator: Puppala, MD            
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52241
Principal Investigator: Ekhard E Ziegler, MD            
United States, Nebraska
Center for Human Nutrition Recruiting
Omaha, Nebraska, United States, 68105
Contact: Khalid A Awad, MD         khalid.awad@nmhs.org    
Principal Investigator: Khalid A Awad, MD            
United States, New Jersey
Midatlantic Neonatology Associates, Inc Recruiting
Morristown, New Jersey, United States, 07962
Contact: Jonathan Swanson, MD            
Principal Investigator: Jonathan Swanson, MD            
United States, Ohio
Children's Hospital Medical Center of Akron Recruiting
Akron, Ohio, United States, 44308
Contact: Anand Kantak, MD     330-543-3193     akantak@chmca.org    
Principal Investigator: Anand Kantak, MD            
Nationwide Children's Hospital Recruiting
Columbus, Ohio, United States, 43205
Contact: Christina Valentine, MD            
Principal Investigator: Christina Valentine, MD            
United States, Utah
University of Utah, Dept of Pediatrics Recruiting
Salt Lake City,, Utah, United States, 84108
Contact: Laurie Moyer-Milleur, MD            
Principal Investigator: Laurie Moyer-Milleur, MD            
United States, Virginia
VCU Children's Medical Center Recruiting
Richmond, Virginia, United States, 23298
Contact: Linda Meloy, MD            
Principal Investigator: Linda Meloy, MD            
Sponsors and Collaborators
Nestlé
Investigators
Principal Investigator: Ekhard Ziegler, MD University of Iowa
  More Information

No publications provided

Responsible Party: Ekhard Ziegler, MD, University of Iowa
ClinicalTrials.gov Identifier: NCT01162798     History of Changes
Other Study ID Numbers: 09.02.US.INF
Study First Received: July 13, 2010
Last Updated: August 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Nestlé:
infant formula
premature infants
Growth and Development

ClinicalTrials.gov processed this record on May 22, 2013