Early Protein Supplementation on Prevention of Hyperkalemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Cynthia Blanco, The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:
NCT00290160
First received: February 8, 2006
Last updated: December 6, 2012
Last verified: December 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double-Blind
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 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

Ages Eligible for Study:   up to 12 Hours
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by The University of Texas Health Science Center at San Antonio

Additional 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
Study First Received: February 8, 2006
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on October 23, 2014