The Use of B-Type Natriuretic Peptide (BNP) to Predict Closure of a Patent Ductus Arteriosus (PDA) in Premature Infants
Information source: University of Virginia
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Indomethacin Therapy; Patent Ductus Arteriosus
Intervention: Withhold standard INDO dose if BNP < 100 pg/ml (Procedure)
Phase: N/A
Status: Completed
Sponsored by: University of Virginia Official(s) and/or principal investigator(s):
D Sc Lim, MD, Principal Investigator, Affiliation: University of Virginia
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.
Clinical Details
Study design: Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Number of indomethacin doses given on study
Secondary outcome: rate of PDA ligationRate of Chronic lung disease
Eligibility
Minimum age: N/A.
Maximum age: 4 Months.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: April 2004
Ending date: March 2007
Last updated: July 10, 2007
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