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

Infant, Premature Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00799123
• Other study ID #: EA2/072/08/2
• Status: Completed
• Phase: N/A
• First received: November 26, 2008
• Last updated: April 9, 2010
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: April 2010
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 48 Hours

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Germany	Charite, Medical University	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany,