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Plasma B-Type Natriuretic Peptide Concentrations in Preterm Infants < 28 Weeks

NCT ID: NCT00528736

Last Updated: 2007-09-14

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

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-04-30

Brief Summary

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The aim of the study was to evaluate BNP in preterm infants \< 28 weeks on the second day of life, when it is still unknown, if a patent ductus arteriosus is hemodynamic significant or not. We hypothesized that high plasma BNP concentrations on day 2 are associated with the need of PDA intervention in the further course.

Detailed Description

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From the study infants blood samples (0.1ml) were collected in K-EDTA microtubes within 24 to 48 hours of age through umbilical artery catheter aspiration or routine venous puncture. The samples were spun at 7000 rpm for 3 minutes. Platelet-free plasma was stored at -20°C until BNP analysis of all collected samples was carried out. The BNP assay was performed using a fully automated immunoassay system ADVIA method for the Centaur System (Bayer Diagnostic Division).

In preterm infants who were treated with indomethacin or surgical ligation we collected additional blood samples 2-4 hours before intervention and 24 hours after the completion of the ductus treatment.

Conditions

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Infant, Premature Ductus Arteriosus, Patent Natriuretic Peptide Brain

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Written parental informed consent
* Preterm infant \< 28 weeks of gestation
* 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

Principal Investigators

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Christoph Czernik, MD

Role: STUDY_DIRECTOR

Department of Neonatology, Charite Virchow Hospital, Medical University Berlin

Locations

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Department of Neonatology, Charite Virchow Hospital, Medical University Berlin

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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EA2/198/05

Identifier Type: -

Identifier Source: org_study_id