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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
  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

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

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00528736     History of Changes
Other Study ID Numbers: EA2/198/05
Study First Received: September 10, 2007
Last Updated: September 12, 2007
Health Authority: Germany: Ethics Commission

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
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Natriuretic Peptide, Brain
Cardiovascular Agents
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014