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

This study has been completed.
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00528736
First received: September 10, 2007
Last updated: September 12, 2007
Last verified: September 2007

September 10, 2007
September 12, 2007
August 2005
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Complete list of historical versions of study NCT00528736 on ClinicalTrials.gov Archive Site
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Plasma B-Type Natriuretic Peptide Concentrations in Preterm Infants < 28 Weeks
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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.

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.

Observational
Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
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  • Infant, Premature
  • Ductus Arteriosus, Patent
  • Natriuretic Peptide Brain
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
April 2007
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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
Both
up to 48 Hours
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00528736
EA2/198/05
No
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Charite University, Berlin, Germany
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Study Director: Christoph Czernik, MD Department of Neonatology, Charite Virchow Hospital, Medical University Berlin
Charite University, Berlin, Germany
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP