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

NCT ID: NCT00799123

Last Updated: 2010-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-12-31

Brief Summary

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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.

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Detailed Description

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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

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Infant, Premature Ductus Arteriosus, Patent Ventricular Function, Left

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

24 Hours

Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Department of Neonatology

Principal Investigators

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Christoph Czernik, MD

Role: PRINCIPAL_INVESTIGATOR

Charite, Medical University Berlin

Locations

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Charite, Medical University

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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EA2/072/08/2

Identifier Type: -

Identifier Source: org_study_id

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