Clinical Trials Directory

Trials / Completed

CompletedNCT00799123

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

Status
Completed
Phase
Study type
Observational
Enrollment
100 (estimated)
Sponsor
Charite University, Berlin, Germany · Academic / Other
Sex
All
Age
24 Hours – 48 Hours
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Timeline

Start date
2008-08-01
Primary completion
2009-12-01
Completion
2009-12-01
First posted
2008-11-27
Last updated
2010-04-12

Locations

1 site across 1 country: Germany

Source: ClinicalTrials.gov record NCT00799123. Inclusion in this directory is not an endorsement.