The Effect of a Liquid Protein Modular on Growth and Outcomes in the NICU
January 29, 2018 updated by: Corrine K. Hanson, PhD, University of Nebraska
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nebraska
-
Omaha, Nebraska, United States
- Alegent Bergan Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 9 months (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Infants less than 2000 gms at birth, receiving maternal breast milk
Exclusion Criteria:
- Infants receiving formula
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / 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
|
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
|
Infants will receive a commerically avaliable liquid protein modular to provide 4 grm/kg/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Growth in premature infants (percentile ranking at 36 weeks CGA)
Time Frame: birth to 36 weeks
|
birth to 36 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
GI tolerance
Time Frame: birth to 36 weeks
|
abdominal distention, feeding tolerance
|
birth to 36 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2012
Primary Completion (ACTUAL)
June 1, 2013
Study Completion (ACTUAL)
June 1, 2013
Study Registration Dates
First Submitted
May 30, 2012
First Submitted That Met QC Criteria
May 31, 2012
First Posted (ESTIMATE)
June 1, 2012
Study Record Updates
Last Update Posted (ACTUAL)
January 31, 2018
Last Update Submitted That Met QC Criteria
January 29, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 12-16432
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.