search
Back to results

Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost

Primary Purpose

Persistent Pulmonary Hypertension, Respiratory Distress Syndrome

Status
Withdrawn
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
iloprost
Sponsored by
Lund University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Persistent Pulmonary Hypertension

Eligibility Criteria

24 Hours - 48 Hours (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Elevated arterial pulmonary pressure GA > 24 GW 24-48 hours of age Ventilator treatment Exclusion Criteria: Congenital anomalies Severe hypotension

Sites / Locations

  • University Hospital in Lund , Department of Pediatrics

Outcomes

Primary Outcome Measures

Oxygenation index
Cardiac output

Secondary Outcome Measures

Full Information

First Posted
September 15, 2005
Last Updated
February 3, 2009
Sponsor
Lund University Hospital
Collaborators
Bayer
search

1. Study Identification

Unique Protocol Identification Number
NCT00216931
Brief Title
Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost
Official Title
Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Withdrawn
Why Stopped
No patients enrolled after three years
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Lund University Hospital
Collaborators
Bayer

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine if iloprost is effective in the treatment of elevated arterial pulmonary pressure in children with ventilator treated respiratory distress syndrome.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Pulmonary Hypertension, Respiratory Distress Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
iloprost
Primary Outcome Measure Information:
Title
Oxygenation index
Title
Cardiac output

10. Eligibility

Sex
All
Minimum Age & Unit of Time
24 Hours
Maximum Age & Unit of Time
48 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elevated arterial pulmonary pressure GA > 24 GW 24-48 hours of age Ventilator treatment Exclusion Criteria: Congenital anomalies Severe hypotension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vineta Fellman, Professor
Organizational Affiliation
Lund University Hospital, Department of Pediatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital in Lund , Department of Pediatrics
City
Lund
ZIP/Postal Code
221 85
Country
Sweden

12. IPD Sharing Statement

Learn more about this trial

Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost

We'll reach out to this number within 24 hrs