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NCT00216931 Clinical Trial

Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost

Respiratory Distress Syndrome Clinical Trial

Official title:
Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00216931
Other study ID # 2004-001551-11
Secondary ID
Status Withdrawn
Phase N/A
First received September 15, 2005
Last updated February 3, 2009
Start date May 2006
Est. completion date October 2008

Study information
Verified date February 2009
Source Lund University Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 40
Est. completion date October 2008
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 48 Hours
Eligibility Inclusion Criteria:

- Elevated arterial pulmonary pressure

- GA > 24 GW

- 24-48 hours of age

- Ventilator treatment

Exclusion Criteria:

- Congenital anomalies

- Severe hypotension

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• iloprost

Locations
Country Name City State
Sweden University Hospital in Lund , Department of Pediatrics Lund

Sponsors (2)
Lead Sponsor Collaborator
Lund University Hospital Bayer

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Oxygenation index
Primary Cardiac output
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