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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.
Information provided by:
University of Virginia Identifier:
First received: July 10, 2007
Last updated: NA
Last verified: March 2007
History: No changes posted
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: 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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00500305

Sponsors and Collaborators
University of Virginia
Principal Investigator: D Sc Lim, MD University of Virginia
  More Information Identifier: NCT00500305     History of Changes
Other Study ID Numbers: HIC# 10946
Study First Received: July 10, 2007
Last Updated: July 10, 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 processed this record on July 19, 2017