The Use of B-Type Natriuretic Peptide (BNP) to Predict Closure of a Patent Ductus Arteriosus (PDA) in Premature Infants

Verified by: University of Virginia, March 2007
First Received: July 10, 2007 | Last Updated: July 10, 2007 | Phase: N/A | Start Date: April 2004
Overall Status: Completed | Estimated Enrollment: 60
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A patent ductus arteriosus (PDA) is associated with increased morbidity in premature infants. Standard indomethacin treatment is associated with intestinal and renal morbidity. B-type natriuretic peptide is elevated in significant PDAs. This study will determine whether BNP guided therapy could reduce doses of indomethacin...

Brief Summary

A patent ductus arteriosus (PDA) is associated with increased morbidity in premature infants. Standard indomethacin treatment is associated with intestinal and renal morbidity.

B-type natriuretic peptide is elevated in significant PDAs. This study will determine whether BNP guided therapy could reduce doses of indomethacin.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Intervention(s) in this Clinical Trial

  • Procedure: Withhold standard INDO dose if BNP < 100 pg/ml

Outcome Measures for this Clinical Trial

Primary Measures

  • Number of indomethacin doses given on study
    • Time Frame: 2 days

Secondary Measures

  • rate of PDA ligation
    • Time Frame: Discharge from NICU
  • Rate of Chronic lung disease
    • Time Frame: 36 weeks corrected gestational age

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Infants with echocardiographically confirmed PDA
  • Infants determined by attending physician to require PDA closure

Exclusion Criteria:

  • infants with congenital hearts disease
  • infants with creatinine value > 2.0

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 4 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: University of Virginia Other

Overall Clinical Trial Officials and Contacts

D Sc Lim, MD Principal Investigator University of Virginia  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00500305

Study ID Number: HIC# 10946

ClinicalTrials.gov Identifier: NCT00500305

Health Authority: United States: Institutional Review Board

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