Treatment of Elevated Arterial Pulmonary Pressure With In... | NCT00216931

Studies
Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost

NCT00216931

Sponsor

Lund University Hospital

Status

Withdrawn

Last Update Posted

Feb 4, 2009Estimated

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Persistent Pulmonary Hypertension
Respiratory Distress Syndrome

Interventions

iloprost

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No patients enrolled after three years

Expanded Access Info

Start Date

May 2006

Primary Completion Date

Not provided

Completion Date

Oct 2008Estimated

First Submitted Date

Sep 15, 2005

First Submission Date that Met QC Criteria

Sep 15, 2005

First Posted Date

Sep 22, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 3, 2009

Last Update Posted Date

Feb 4, 2009Estimated

Name	Class
Bayer	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
iloprost	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elevated arterial pulmonary pressure
GA > 24 GW
24-48 hours of age
Ventilator treatment

Exclusion Criteria:

Congenital anomalies
Severe hypotension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Hours

Maximum Age

48 Hours

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vineta Fellman, Professor	Lund University Hospital, Department of Pediatrics	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital in Lund , Department of Pediatrics		Lund	Lund	221 85	Sweden

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016285	Iloprost

Ancestor Terms

ID	Term
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids
D005231	Fatty Acids, Unsaturated

Browse Leaves

Not provided

Browse Branches

Not provided

Measure	Description	Time Frame
Oxygenation index
Cardiac output