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

NCT00725647 | Completed

• 1 other identifier: 04/Q0803/98
• Study Type: observational
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Ductus Arteriosus, Patent

Keywords

N terminal B type natriuretic peptide; echocardiography; diagnosis; atrial natriuretic peptides; preterm infant

Study Arms (1)

Treated PDA

Infants who had a PDA which the attending physicians treated medically or surgically.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants in a tertiary level neonatal intensive care unit

You may qualify if:

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

You may not qualify if:

• Known structural heart abnormality other than PDA

Sponsors & Collaborators

• St George's, University of London: lead
• National Health Service, United Kingdom: collaborator
• Medical Research Council: collaborator

Related Publications (1)

• 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.

  PMID: 19432837 RESULT

MeSH Terms

Conditions

Ductus Arteriosus, Patent; Disease; Premature Birth

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Santhanakrishnan Ramakrishnan, MB MRCPCH

  St George's Healthcare NHS Trust

  PRINCIPAL INVESTIGATOR

• Anthony F Williams, MB FRCPCH

  St George's, University of London

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: May 1, 2005
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: September 18, 2009

Record last verified: 2009-09