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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.
 
ClinicalTrials.gov Identifier: NCT01162798
Recruitment Status : Completed
First Posted : July 15, 2010
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Nestlé

Tracking Information
First Submitted Date  ICMJE July 13, 2010
First Posted Date  ICMJE July 15, 2010
Last Update Posted Date November 4, 2014
Study Start Date  ICMJE September 2010
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
Growth [ Time Frame: 4 months ]
weight gain assessed monthly
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 14, 2010)
  • growth, tolerance, morbidity [ Time Frame: 6 months ]
    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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Preterm Infant Growth
Official Title  ICMJE Growth of Preterm Infants Consuming Formula
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Condition  ICMJE
  • Growth
  • Development
  • Infant
Intervention  ICMJE
  • Other: infant formula
    test infant formula fed to infants until 6 months corrected gestational age
    Other Name: test infant formula
  • Other: control infant formula
    commercially available infant formula
    Other Name: commercially available infant formula fed to infants until 6 months corrected gestational age
Study Arms  ICMJE
  • Active Comparator: Control
    commercially available formula
    Intervention: Other: control infant formula
  • Experimental: Test
    test formula
    Intervention: Other: infant formula
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 14, 2010)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 1 Month   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01162798
Other Study ID Numbers  ICMJE 09.02.US.INF
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Nestlé
Study Sponsor  ICMJE Nestlé
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ekhard Ziegler, MD University of Iowa
PRS Account Nestlé
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP