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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00528736
First Posted: September 12, 2007
Last Update Posted: September 14, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Charite University, Berlin, Germany
  Purpose
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.

Condition
Infant, Premature Ductus Arteriosus, Patent Natriuretic Peptide Brain

Study Type: Observational
Study Design: Observational Model: Defined Population
Primary Purpose: Screening
Time Perspective: Longitudinal
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Enrollment: 82
Study Start Date: August 2005
Study Completion Date: April 2007
Detailed 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00528736


Locations
Germany
Department of Neonatology, Charite Virchow Hospital, Medical University Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Study Director: Christoph Czernik, MD Department of Neonatology, Charite Virchow Hospital, Medical University Berlin
  More Information

ClinicalTrials.gov Identifier: NCT00528736     History of Changes
Other Study ID Numbers: EA2/198/05
First Submitted: September 10, 2007
First Posted: September 12, 2007
Last Update Posted: September 14, 2007
Last Verified: September 2007

Keywords provided by Charite University, Berlin, Germany:
preterm infants < 28 weeks
B-type natriuretic peptide
prediction
ductus intervention

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs