Early Protein Supplementation on Prevention of Hyperkalemia

This study has been completed.

Sponsored by:	The University of Texas Health Science Center at San Antonio
Information provided by:	The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier:	NCT00290160

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	The Effect of Early Protein Supplementation on Prevention of Hyperkalemia in Extremely Low Birth Weight Infants

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

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

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

UTHSCSA

More Information

Publications indexed to this study:

Blanco CL, Falck A, Green BK, Cornell JE, Gong AK. Metabolic responses to early and high protein supplementation in a randomized trial evaluating the prevention of hyperkalemia in extremely low birth weight infants. J Pediatr. 2008 Oct;153(4):535-40. Epub 2008 Jun 27.

Study ID Numbers:	012-9000-400
Study First Received:	February 8, 2006
Last Updated:	February 8, 2006
ClinicalTrials.gov Identifier:	NCT00290160
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

Study placed in the following topic categories:

Body Weight
Birth Weight
Metabolic Diseases
Hyperglycemia

Hyperkalemia
Water-Electrolyte Imbalance
Metabolic disorder

ClinicalTrials.gov processed this record on January 16, 2009