NCT00216931

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2006

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

February 4, 2009

Status Verified

February 1, 2009

First QC Date

September 15, 2005

Last Update Submit

February 3, 2009

Conditions

Persistent Pulmonary HypertensionRespiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

  • Oxygenation index

  • Cardiac output

Interventions

iloprostDRUG

Eligibility Criteria

Age24 Hours - 48 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Elevated arterial pulmonary pressure
  • GA \> 24 GW
  • hours of age
  • Ventilator treatment

You may not qualify if:

  • Congenital anomalies
  • Severe hypotension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital in Lund , Department of Pediatrics

Lund, Lund, 221 85, Sweden

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Iloprost

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Intervention Hierarchy (Ancestors)

Prostaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Vineta Fellman, Professor

    Lund University Hospital, Department of Pediatrics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2005

First Posted

September 22, 2005

Study Start

May 1, 2006

Study Completion

October 1, 2008

Last Updated

February 4, 2009

Record last verified: 2009-02

Locations

SE(1)