Plasma N-terminal proBNP Concentrations and Patent Ductus Arteriosus in Preterm Babies
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Purpose
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 |
|---|
|
Ductus Arteriosus, Patent |
| Study Type: | Observational |
| Study Design: | 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. |
| Enrollment: | 102 |
| Study Start Date: | May 2005 |
| Study Completion Date: | June 2007 |
| Primary Completion Date: | June 2007 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Treated PDA
Infants who had a PDA which the attending physicians treated medically or surgically.
|
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Preterm infants in a tertiary level neonatal intensive care unit
Inclusion Criteria:
- Preterm babies under 34-weeks gestation admitted to the neonatal intensive care unit
Exclusion Criteria:
- Known structural heart abnormality other than PDA
Contacts and Locations| 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 |
More Information
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 |
| Study First Received: | July 28, 2008 |
| Last Updated: | September 17, 2009 |
| Health Authority: | United Kingdom: Research Ethics Committee |
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 |
Natriuretic Peptide, Brain Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013