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

This study has been completed.
Sponsor:
Collaborators:
National Health Service, United Kingdom
Medical Research Council
Information provided by:
St George's, University of London
ClinicalTrials.gov Identifier:
NCT00725647
First received: July 28, 2008
Last updated: September 17, 2009
Last verified: September 2009

July 28, 2008
September 17, 2009
May 2005
June 2007   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00725647 on ClinicalTrials.gov Archive Site
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Plasma N-terminal proBNP Concentrations and Patent Ductus Arteriosus in Preterm Babies
A Study of the Value of Plasma N-terminal proBNP Concentrations for Diagnosing Patent Ductus Arteriosus in Preterm Babies.

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.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Preterm infants in a tertiary level neonatal intensive care unit

Ductus Arteriosus, Patent
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Treated PDA
Infants who had a PDA which the attending physicians treated medically or surgically.
Ramakrishnan S, Heung YM, Round J, Morris TP, Collinson P, Williams AF. Early N-terminal pro-brain natriuretic peptide measurements predict clinically significant ductus arteriosus in preterm infants. Acta Paediatr. 2009 Aug;98(8):1254-9. Epub 2009 Apr 30.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
June 2007
June 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Known structural heart abnormality other than PDA
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT00725647
04/Q0803/98
No
Dr Santhanakrishnan Ramakrishnan (Principal investigator), St George's Healthcare NHS Trust
St George's, University of London
  • National Health Service, United Kingdom
  • Medical Research Council
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
St George's, University of London
September 2009

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