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
  Purpose

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.


Condition Intervention
Problem With Growth of an Infant
Dietary Supplement: Powder protein modular
Dietary Supplement: Liquid protein modular

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU

Resource links provided by NLM:


Further study details as provided by University of Nebraska:

Primary Outcome Measures:
  • Growth in premature infants (percentile ranking at 36 weeks CGA) [ Time Frame: birth to 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • GI tolerance [ Time Frame: birth to 36 weeks ] [ Designated as safety issue: Yes ]
    abdominal distention, feeding tolerance


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Dietary Supplement: Powder protein modular
Infants will receive powder protein modular to achieve 4 grm/kg/day
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
Dietary Supplement: Liquid protein modular
Infants will receive a commerically avaliable liquid protein modular to provide 4 grm/kg/day

  Eligibility

Ages Eligible for Study:   up to 40 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Infants receiving formula
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609868

Contacts
Contact: Corrine Hanson, PhD 402-559-3658 ckhanson@unmc.edu

Locations
United States, Nebraska
Alegent Bergan Hospital Not yet recruiting
Omaha, Nebraska, United States
Contact: Corrine Hanson, Phd    402-559-3658    ckhanson@unmc.edu   
Sponsors and Collaborators
University of Nebraska
Alegent Health Bergan Mercy Medical Center
  More Information

No publications provided

Responsible Party: Corrine K. Hanson, IRB Administrator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01609868     History of Changes
Other Study ID Numbers: 12-16432
Study First Received: May 30, 2012
Last Updated: May 31, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Nebraska:
premature infant feeding protein

ClinicalTrials.gov processed this record on April 17, 2014