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Study of Sildenafil to Treat Newborns With Persistent Pulmonary Hypertension

NCT01409031 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2019-02-01

Study results available
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Summary

The purpose of this study is to determine whether intravenous sildenafil reduces pulmonary artery pressure and improves oxygenation in near-term and term infants with persistent pulmonary hypertension.

Conditions

Interventions

DRUG

Intravenous Sildenafil

0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.

OTHER

Placebo

An equivalent volume of placebo (D5W)infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • State University of New York at Buffalo

    collaborator OTHER

  • Vanderbilt University

    collaborator OTHER

  • Ann & Robert H Lurie Children's Hospital of Chicago

    collaborator OTHER

  • University of Utah

    collaborator OTHER

  • University of Alabama at Birmingham

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • John Kinsella, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
72 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2013-10-31
Completion
2013-10-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01409031 on ClinicalTrials.gov