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Plasma N-terminal proBNP Concentrations and Patent Ductus Arteriosus in Preterm Babies

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.
ClinicalTrials.gov Identifier: NCT00725647
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : September 18, 2009
Sponsor:
Collaborators:
National Health Service, United Kingdom
Medical Research Council
Information provided by:
St George's, University of London

Brief Summary:

Premature babies are affected by a condition known as "patent ductus arteriosus" in which the ductus arteriosus (a normal structure) fails to close after birth as it should. A very large ductus can put extra strain on the heart and lungs, making the baby's breathing dependent on a mechanical ventilator. Attending physicians can close the duct with medical\or surgical treatment but assessing whether this is justified can be difficult. The physician usually bases this decision on assessment of the baby's general condition and an ultrasound evaluation of the heart (called an "echocardiogram") but the last is particularly dependent on availability of skilled operators.

The investigators have examined whether blood levels of a hormone called B-type natriuretic peptide (Nt pro-BNP)in the first week of life predict the need to treat a ductus arteriosus. This hormone is produced by the heart if it is under strain. If the test is helpful it could reduce dependence of physicians on echocardiography by skilled operators.

Babies who were recruited had blood samples collected on days 1, 2, 3 and 7 for measurement of Nt pro-BNP. Each baby also had an echocardiogram performed between the fifth and seventh day of life. Decisions about treatment of the duct were made by attending physicians independent of the study. Physicians, investigators and echocardiographers were blinded to knowledge of the Nt pro-BNP concentration. Nt pro-BNP was also measured before and after treatment in all babies who had a PDA treated and echocardiography performed to confirm closure.

Receiver operating characteristics (ROC) curves were used to assess the predictive value of Nt pro-BNP for samples collected at each time point. The investigators also compared the Nt pro-BNP levels in samples collected before and after treatment to assess the usefulness of Nt pr-BNP as an indicator of duct closure.


Condition or disease
Ductus Arteriosus, Patent

Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study of the Value of Plasma N-terminal proBNP Concentrations for Diagnosing Patent Ductus Arteriosus in Preterm Babies.
Study Start Date : May 2005
Primary Completion Date : June 2007
Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort
Treated PDA
Infants who had a PDA which the attending physicians treated medically or surgically.




Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Preterm infants in a tertiary level neonatal intensive care unit
Criteria

Inclusion Criteria:

  • Preterm babies under 34-weeks gestation admitted to the neonatal intensive care unit

Exclusion Criteria:

  • Known structural heart abnormality other than PDA

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): NCT00725647


Sponsors and Collaborators
St George's, University of London
National Health Service, United Kingdom
Medical Research Council
Investigators
Principal Investigator: Santhanakrishnan Ramakrishnan, MB MRCPCH St George's Healthcare NHS Trust
Study Director: Anthony F Williams, MB FRCPCH St George's, University of London

Publications:
Responsible Party: Dr Santhanakrishnan Ramakrishnan (Principal investigator), St George's Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT00725647     History of Changes
Other Study ID Numbers: 04/Q0803/98
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by St George's, University of London:
N terminal B type natriuretic peptide
echocardiography
diagnosis
atrial natriuretic peptides
preterm infant

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities