Do Elevated BNP Levels Predict Hemodynamically Significant PDAs

NCT01497054 | Completed

• 1 other identifier: 3155
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if B type natriuretic peptide (BNP) levels can be used to predict a hemodynamically significant patent ductus arteriosus (PDA). This peptide is produced by the ventricles in the heart when they are under stress, such as when a ductus remains open. If we can use a simple and inexpensive blood test to determine whether a PDA needs to be treated, we can potentially treat infants sooner than if they needed to wait for the availability of a cardiologist to perform an echocardiogram. This might decrease some of the deleterious effects of PDAs on the preterm infant such as bronchopulmonary dysplasia, necrotizing enterocolitis, renal hypoperfusion, and pulmonary hemorrhage. In a situation where follow up echocardiogram after a course of medical therapy shows persistent PDA, this test may help to decide whether this baby needs further treatment, either medical or surgical.

Conditions

Patent Ductus Arteriosus

Keywords

B type natriuretic peptide; Patent Ductus Arteriosus; Preterm infant

Outcome Measures

Primary Outcomes (1)

• BNP level and size of PDA

  BNP levels measured at several time points during first 2 weeks of life and compared to findings on echocardiogram to see if size of PDA correlated with BNP level.

  within first 2 weeks of life

Eligibility Criteria

• Age: 1 Hour - 24 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Preterm infants between 24 0/7 weeks gestation and 31 6/7 weeks gestation.

You may qualify if:

• gestational age between 24 0/7 weeks gestation and 31 6/7 weeks gestation. - Infants must be enrolled by 24 hours of life.

You may not qualify if:

• congenital heart disease,
• necrotizing enterocolitis,
• culture positive sepsis or culture negative but treated for presumed sepsis.

Sponsors & Collaborators

• Albany Medical College: lead
• Alere, Inc.: collaborator

Study Sites (1)

Albany Medical Center Neonatal Intesive Care Unit

Albany, New York, 12208, United States

Location

Related Publications (2)

• Sanjeev S, Pettersen M, Lua J, Thomas R, Shankaran S, L'Ecuyer T. Role of plasma B-type natriuretic peptide in screening for hemodynamically significant patent ductus arteriosus in preterm neonates. J Perinatol. 2005 Nov;25(11):709-13. doi: 10.1038/sj.jp.7211383.

  PMID: 16222347 BACKGROUND

• Holmstrom H, Hall C, Thaulow E. Plasma levels of natriuretic peptides and hemodynamic assessment of patent ductus arteriosus in preterm infants. Acta Paediatr. 2001 Feb;90(2):184-91. doi: 10.1080/080352501300049406.

  PMID: 11236049 BACKGROUND

MeSH Terms

Conditions

Ductus Arteriosus, Patent; Premature Birth

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Kate A Tauber, MD

  Albany Medical College

  PRINCIPAL INVESTIGATOR

• Upender K Munshi, MD

  Albany Medical College

  STUDY DIRECTOR

• Robin Doyle, MD

  Capital Distric Pediatric Cardiology, affiliated with Albany Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 22, 2011
• Study Start: December 1, 2011
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 4, 2013

Record last verified: 2011-12

Locations

US (1)