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

Sponsored by:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT00528736

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

Drug Information available for: Nesiritide

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Longitudinal, Defined Population, Prospective Study

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

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

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

Keywords provided by Charite University, Berlin, Germany:

preterm infants < 28 weeks
B-type natriuretic peptide
prediction
ductus intervention

Study placed in the following topic categories:

Natriuretic Peptide, Brain
Heart Diseases
Cardiovascular Abnormalities

Congenital Abnormalities
Heart Defects, Congenital
Ductus Arteriosus, Patent

Additional relevant MeSH terms:

Natriuretic Agents
Therapeutic Uses
Physiological Effects of Drugs

Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009