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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Nebraska.
Recruitment status was  Not yet recruiting
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
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: 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 August 18, 2014