Back to resultsThe Use of B-type Natriuretic Peptide (BNP) to Predict Closure of a Patent Ductus Arteriosus (PDA) in Premature Infants
Primary Purpose
Indomethacin Therapy, Patent Ductus Arteriosus
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Withhold standard INDO dose if BNP < 100 pg/ml
Sponsored by
About this trial
This is an interventional diagnostic trial for Indomethacin Therapy focused on measuring indomethacin therapy, patent ductus arteriosus
Eligibility 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
Sites / Locations
Outcomes
Primary Outcome Measures
Number of indomethacin doses given on study
Secondary Outcome Measures
rate of PDA ligation
Rate of Chronic lung disease
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00500305
Brief Title
The Use of B-type Natriuretic Peptide (BNP) to Predict Closure of a Patent Ductus Arteriosus (PDA) in Premature Infants
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Virginia
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Indomethacin Therapy, Patent Ductus Arteriosus
Keywords
indomethacin therapy, patent ductus arteriosus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Withhold standard INDO dose if BNP < 100 pg/ml
Primary Outcome Measure Information:
Title
Number of indomethacin doses given on study
Time Frame
2 days
Secondary Outcome Measure Information:
Title
rate of PDA ligation
Time Frame
Discharge from NICU
Title
Rate of Chronic lung disease
Time Frame
36 weeks corrected gestational age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
4 Months
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
D Sc Lim, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
The Use of B-type Natriuretic Peptide (BNP) to Predict Closure of a Patent Ductus Arteriosus (PDA) in Premature Infants
We'll reach out to this number within 24 hrs