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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00500305
First Posted: July 12, 2007
Last Update Posted: July 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Virginia
  Purpose
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 Intervention
Indomethacin Therapy Patent Ductus Arteriosus Procedure: Withhold standard INDO dose if BNP < 100 pg/ml

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Resource links provided by NLM:


Further study details as provided by University of Virginia:

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

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

Enrollment: 60
Study Start Date: April 2004
Study Completion Date: March 2007
  Eligibility

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
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
  Contacts and Locations
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
Investigators
Principal Investigator: D Sc Lim, MD University of Virginia
  More Information

ClinicalTrials.gov Identifier: NCT00500305     History of Changes
Other Study ID Numbers: HIC# 10946
First Submitted: July 10, 2007
First Posted: July 12, 2007
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