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

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ClinicalTrials.gov Identifier: NCT01609868
Recruitment Status : Completed
First Posted : June 1, 2012
Last Update Posted : January 31, 2018
Sponsor:
Collaborator:
Alegent Health Bergan Mercy Medical Center
Information provided by (Responsible Party):
Corrine K. Hanson, PhD, University of Nebraska

Brief Summary:
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 or disease Intervention/treatment
Problem With Growth of an Infant Dietary Supplement: Powder protein modular Dietary Supplement: Liquid protein modular

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU
Actual Study Start Date : June 2012
Primary Completion Date : June 2013
Study Completion Date : June 2013

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Growth in premature infants (percentile ranking at 36 weeks CGA) [ Time Frame: birth to 36 weeks ]

Secondary Outcome Measures :
  1. GI tolerance [ Time Frame: birth to 36 weeks ]
    abdominal distention, feeding tolerance



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 40 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Infants receiving formula

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01609868


Locations
United States, Nebraska
Alegent Bergan Hospital
Omaha, Nebraska, United States
Sponsors and Collaborators
University of Nebraska
Alegent Health Bergan Mercy Medical Center

Responsible Party: Corrine K. Hanson, PhD, IRB Administrator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01609868     History of Changes
Other Study ID Numbers: 12-16432
First Posted: June 1, 2012    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Corrine K. Hanson, PhD, University of Nebraska:
premature infant feeding protein