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

NCT ID: NCT00500305

Last Updated: 2018-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Indomethacin Therapy Patent Ductus Arteriosus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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Withhold standard INDO dose if BNP < 100 pg/ml

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

4 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Principal Investigators

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D Sc Lim, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Other Identifiers

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10946

Identifier Type: -

Identifier Source: org_study_id

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