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

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ClinicalTrials.gov Identifier: NCT00500305
Recruitment Status : Completed
First Posted : July 12, 2007
Last Update Posted : July 12, 2007
Information provided by:
University of Virginia

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.

Condition or disease Intervention/treatment
Indomethacin Therapy Patent Ductus Arteriosus Procedure: Withhold standard INDO dose if BNP < 100 pg/ml

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Study Start Date : April 2004
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Number of indomethacin doses given on study [ Time Frame: 2 days ]

Secondary Outcome Measures :
  1. rate of PDA ligation [ Time Frame: Discharge from NICU ]
  2. Rate of Chronic lung disease [ Time Frame: 36 weeks corrected gestational age ]

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 4 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00500305

Sponsors and Collaborators
University of Virginia
Principal Investigator: D Sc Lim, MD University of Virginia

ClinicalTrials.gov Identifier: NCT00500305     History of Changes
Other Study ID Numbers: HIC# 10946
First Posted: July 12, 2007    Key Record Dates
Last Update Posted: July 12, 2007
Last Verified: March 2007

Keywords provided by University of Virginia:
indomethacin therapy
patent ductus arteriosus

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs