Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Endpoint Classification: Safety/Efficacy Study
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
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided 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
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases processed this record on November 27, 2014