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:
University of Nebraska
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
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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 May 21, 2013