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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00500305
Enrollment
60
Registered
2007-07-12
Start date
2004-04-30
Completion date
2007-03-31
Last updated
2018-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Indomethacin Therapy, Patent Ductus Arteriosus

Keywords

indomethacin therapy, patent ductus arteriosus

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.

Interventions

PROCEDUREWithhold standard INDO dose if BNP < 100 pg/ml

Sponsors

University of Virginia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 4 Months
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

Design outcomes

Primary

MeasureTime frame
Number of indomethacin doses given on study2 days

Secondary

MeasureTime frame
rate of PDA ligationDischarge from NICU
Rate of Chronic lung disease36 weeks corrected gestational age

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026