Clinical trial NCT00725647: Plasma N-terminal proBNP Concentrations and Patent Ductus Arteriosus in Preterm Babies
Official title: A Study of the Value of Plasma N-terminal proBNP Concentrations for Diagnosing Patent Ductus Arteriosus in Preterm Babies.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ductus Arteriosus, Patent
Keywords: N terminal B type natriuretic peptide
echocardiography
diagnosis
atrial natriuretic peptides
preterm infant
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: National Health Service, United Kingdom
name: Medical Research Council
First posted: 2008-07-30
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants in a tertiary level neonatal intensive care unit

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.


Eligibility 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: St George's Healthcare NHS Trust
name: Santhanakrishnan Ramakrishnan, MB MRCPCH
role: PRINCIPAL_INVESTIGATOR
affiliation: St George's, University of London
name: Anthony F Williams, MB FRCPCH
role: STUDY_DIRECTOR
References:
citation: 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. doi: 10.1111/j.1651-2227.2009.01315.x. Epub 2009 Apr 30.