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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:
Information provided by:
University of Virginia
ClinicalTrials.gov Identifier:
NCT00500305
First received: July 10, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

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

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500305

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

No publications provided

ClinicalTrials.gov Identifier: NCT00500305     History of Changes
Other Study ID Numbers: HIC# 10946
Study First Received: July 10, 2007
Last Updated: July 10, 2007
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013