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Early Protein Supplementation on Prevention of Hyperkalemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00290160
First Posted: February 10, 2006
Last Update Posted: December 10, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cynthia Blanco, The University of Texas Health Science Center at San Antonio
  Purpose
Evaluate if early protein supplementation decreases the incidence of hyperkalemia in Extremely Low Birth Weight Infants (babies less than 1,000 grams birth weight).

Condition Intervention
Hyperkalemia Behavioral: Protein supplementation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: The Effect of Early Protein Supplementation on Prevention of Hyperkalemia in Extremely Low Birth Weight Infants

Resource links provided by NLM:


Further study details as provided by Cynthia Blanco, The University of Texas Health Science Center at San Antonio:

Primary Outcome Measures:
  • Incidence of hyperkalemia in between groups

Secondary Outcome Measures:
  • Incidence of hyperglycemia, post-natal growth, neurodevelopmental outcome at 18 months

Estimated Enrollment: 62
Study Start Date: December 2002
Study Completion Date: July 2007
Primary Completion Date: September 2005 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Hours   (Child)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria: ELBW infants with birth weight <1000 grams . Enrollment within the first 12 hr of life.

Exclusion Criteria: major congenital anomalies; gestational age less than 24 weeks, infants not resuscitated, death.

  Contacts and Locations
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): NCT00290160


Locations
United States, Texas
University Health System
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
Principal Investigator: Cynthia L Blanco, MD University of Texas
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cynthia Blanco, Associate Professor, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT00290160     History of Changes
Other Study ID Numbers: 012-9000-400
First Submitted: February 8, 2006
First Posted: February 10, 2006
Last Update Posted: December 10, 2012
Last Verified: December 2012

Keywords provided by Cynthia Blanco, The University of Texas Health Science Center at San Antonio:
Hyperkalemia
Protein
Hyperglycemia
ELBW

Additional relevant MeSH terms:
Hyperkalemia
Water-Electrolyte Imbalance
Metabolic Diseases