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The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU

This study is not yet open for participant recruitment.
Verified May 2012 by University of Nebraska
Sponsor:
Collaborator:
Alegent Health Bergan Mercy Medical Center
Information provided by (Responsible Party):
Corrine K. Hanson, University of Nebraska
ClinicalTrials.gov Identifier:
NCT01609868
First received: May 30, 2012
Last updated: May 31, 2012
Last verified: May 2012
History of Changes

May 30, 2012
May 31, 2012
June 2012
June 2013   (final data collection date for primary outcome measure)
Growth in premature infants (percentile ranking at 36 weeks CGA) [ Time Frame: birth to 36 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01609868 on ClinicalTrials.gov Archive Site
GI tolerance [ Time Frame: birth to 36 weeks ] [ Designated as safety issue: Yes ]
abdominal distention, feeding tolerance
Same as current
Not Provided
Not Provided
 
The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU
The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU

The investigators hypothesis that premature infants receiving a commercially available liquid protein modular will have improved growth when compared with premature infants receiving a commercially available powder protein modular.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Problem With Growth of an Infant
  • Dietary Supplement: Powder protein modular
    Infants will receive powder protein modular to achieve 4 grm/kg/day
  • Dietary Supplement: Liquid protein modular
    Infants will receive a commerically avaliable liquid protein modular to provide 4 grm/kg/day
  • Active Comparator: control
    infants in this arm will receive the current treatment that is standard of care for these infants, powder protein modular to achieve 4 gm/kg/day
    Intervention: Dietary Supplement: Powder protein modular
  • Experimental: experimental
    this group will receive a liquid protein modular that recently became commercially avaliable, to achieve the same protein of 4 grm/kg/day as the powder comparision group
    Intervention: Dietary Supplement: Liquid protein modular
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infants less than 2000 gms at birth, receiving maternal breast milk

Exclusion Criteria:

  • Infants receiving formula
Both
up to 40 Weeks
No
Contact: Corrine Hanson, PhD 402-559-3658 ckhanson@unmc.edu
United States
 
NCT01609868
12-16432
No
Corrine K. Hanson, University of Nebraska
University of Nebraska
Alegent Health Bergan Mercy Medical Center
Not Provided
University of Nebraska
May 2012

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