Preterm Infant Growth

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Nestlé
ClinicalTrials.gov Identifier:
NCT01162798
First received: July 13, 2010
Last updated: October 31, 2013
Last verified: October 2013
  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:


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
Primary Completion Date: October 2013 (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
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, see Learn About Clinical Studies.

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

Locations
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
Nestlé
Investigators
Principal Investigator: Ekhard Ziegler, MD University of Iowa
  More Information

No publications provided

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT01162798     History of Changes
Other Study ID Numbers: 09.02.US.INF
Study First Received: July 13, 2010
Last Updated: October 31, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 23, 2014