Urine NT-proBNP Levels and Echocardiographic Findings in Very Low Birth Weight (VLBW) Infants

This study is currently recruiting participants.

Verified by Charite University, Berlin, Germany, July 2009

First Received: November 26, 2008 Last Updated: July 31, 2009 History of Changes

Sponsored by:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00799123

Purpose

The aim of the study is to evaluate urine NT-proBNP levels and new Echocardiographic Findings in VLBW infants.

The investigators hypothesize that high urine NT-proBNP concentrations are associated with a hemodynamically significant ductus arteriosus. The investigators also hypothesized that new echocardiographic parameters such as isovolumic relaxation time (IVRT)is useful for the prediction of ductus intervention.

Condition
Infant, Premature Ductus Arteriosus, Patent Ventricular Function, Left

Study Type:	Observational
Study Design:	Cohort, Prospective

Resource links provided by NLM:

MedlinePlus related topics: Urine and Urination

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Estimated Enrollment:	100
Study Start Date:	August 2008
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Detailed Description:

Urine samples were collected within 24 to 48 hours of age, on day 7, on day 14 and on day 28 of life. The samples were spun and the platelet-free urine was stored at -80°C until NT-proBNP analysis. The NT-proBNP assay was performed with an automated immunoassay (Roche Diagnostics). Color Doppler and tissue Doppler echocardiography was determined at the same time as the urine collection. New echo parameters such as IVRT, tissue velocity, strain and strain rate were measured and compared with the standard parameters for significant ductus arteriosus.

Furthermore we compared the tissue Doppler measurements with clinical findings.

Eligibility

Ages Eligible for Study:	up to 48 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

VLBW infants

Criteria

Inclusion Criteria:

Written parental informed consent
VLBW infants
Admitted to our NICU within 48 hours after birth

Exclusion Criteria:

No written parental informed consent
Congenital heart disease
Death

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00799123

Contacts

Contact: Christoph Czernik, MD

004930450566122

christoph.czernik@charite.de

Locations

Germany
Charite, Medical University	Recruiting
Berlin, Germany, 13353
Contact: Christoph Czernik, MD 004930566122 christoph.czernik@charite.de
Principal Investigator: Christoph Czernik, MD

Sponsors and Collaborators

Charite University, Berlin, Germany

Investigators

Principal Investigator:

Christoph Czernik, MD

Charite, Medical University Berlin

More Information

No publications provided

Responsible Party:	Department of Neonatology ( Charite University, Berlin, Germany )
Study ID Numbers:	EA2/072/08/2
Study First Received:	November 26, 2008
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00799123 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:

NT-proBNP

Study placed in the following topic categories:

Body Weight
Birth Weight
Signs and Symptoms
Heart Diseases

Cardiovascular Abnormalities
Congenital Abnormalities
Heart Defects, Congenital
Ductus Arteriosus, Patent

Additional relevant MeSH terms:

Heart Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases

Congenital Abnormalities
Heart Defects, Congenital
Ductus Arteriosus, Patent

ClinicalTrials.gov processed this record on September 10, 2009