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...
Date First Received: July 10, 2007
Last Updated: July 10, 2007
Verified by: University of Virginia, March 2007
Clinical Trial Phase: N/A | Start Date: April 2004
Overall Status: Completed
Estimated Enrollment: 60
Brief Summary
Condition Keyword(s):
Intervention(s):
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: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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
- Time Frame: 2 days
Secondary Measures
- rate of PDA ligation
- Time Frame: Discharge from NICU
- Time Frame: Discharge from NICU
- Rate of Chronic lung disease
- Time Frame: 36 weeks corrected gestational age
- 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 Sponsor Information
Lead Sponsor: University of Virginia
Overall Clinical Trial Officials and Contacts
D Sc Lim, MD Principal Investigator University of Virginia
Additional Information
Information obtained from ClinicalTrials.gov on September 05, 2008
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
Clinical Trials Authorship and Review
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