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

• Sponsor: University of Virginia (Other)
• Overall Status: Completed
• CT.gov ID: NCT00500305
• Collaborator: (none)
• Enrollment: 60
• Duration (Months): 35

Study Details

Study Description

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	Phase
Indomethacin Therapy; Patent Ductus Arteriosus	Procedure: Withhold standard INDO dose if BNP < 100 pg/ml	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Study Start Date: Apr 1, 2004
• Actual Study Completion Date: Mar 1, 2007

Outcome Measures

Primary Outcome Measures

1. Number of indomethacin doses given on study [2 days]

Secondary Outcome Measures

1. rate of PDA ligation [Discharge from NICU]

2. Rate of Chronic lung disease [36 weeks corrected gestational age]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 4 Months
• 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

Locations

No locations specified.

Sponsors and Collaborators

• University of Virginia

Investigators

• Principal Investigator: D Sc Lim, MD, University of Virginia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00500305
• Other Study ID Numbers: 10946
• First Posted: Jul 12, 2007
• Last Update Posted: May 7, 2018
• Last Verified: May 1, 2018

• Keywords provided by , ,: indomethacin therapy; patent ductus arteriosus
• Additional relevant MeSH terms: Ductus Arteriosus, Patent

Study Results

No Results Posted as of May 7, 2018