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

History of Changes

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:

MedlinePlus related topics: Birth Weight Hyperglycemia

U.S. FDA Resources

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

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):

Blanco CL, Gong AK, Schoolfield J, Green BK, Daniels W, Liechty EA, Ramamurthy R. Impact of early and high amino acid supplementation on ELBW infants at 2 years. J Pediatr Gastroenterol Nutr. 2012 May;54(5):601-7.

Blanco CL, Gong AK, Green BK, Falck A, Schoolfield J, Liechty EA. Early changes in plasma amino acid concentrations during aggressive nutritional therapy in extremely low birth weight infants. J Pediatr. 2011 Apr;158(4):543-548.e1. Epub 2010 Dec 3.

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.

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
Water-Electrolyte Imbalance
Metabolic Diseases

ClinicalTrials.gov processed this record on May 22, 2013

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