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NCT00528736 Clinical Trial

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

Infant, Premature Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00528736
Other study ID # EA2/198/05
Secondary ID
Status Completed
Phase N/A
First received September 10, 2007
Last updated September 12, 2007
Start date August 2005
Est. completion date April 2007

Study information
Verified date September 2007
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 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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 82
Est. completion date April 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 48 Hours
Eligibility 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

Study Design

Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
Germany Department of Neonatology, Charite Virchow Hospital, Medical University Berlin Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

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