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Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients

NCT00981591 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2015-01-19

No results posted yet for this study

Summary

The purpose of this study is to determine whether inhaled iloprost is safe and effective in pediatric patients with pulmonary hypertension who are sick in the intensive care unit.

Conditions

  • Pulmonary Hypertension
  • Neonatal Hypoxic Respiratory Failure
  • Persistent Pulmonary Hypertension of Newborn
  • Congenital Heart Defects
  • Acute Respiratory Distress Syndrome

Interventions

DRUG

Iloprost

Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours; uptitrated to effect, to maximum dose of 30 mcg every 30 minutes

DRUG

Placebo

Inhaled via Aerogen nebulizer, 0.5 mcg/kg every 2 hours or more

Sponsors & Collaborators

  • Actelion

    collaborator INDUSTRY

  • Seattle Children's Hospital

    lead OTHER

Principal Investigators

  • Delphine Yung, MD · Seattle Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2013-03-31
Completion
2013-03-31

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Entities

Drugs

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 NCT00981591 on ClinicalTrials.gov