Persistent Pulmonary HypertensionNCT00216931
Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost
A study testing iloprost in people with Persistent Pulmonary Hypertension and Respiratory Distress Syndrome, run by Lund University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 24 to 48 hours
- Conditions the study is for
- Persistent Pulmonary Hypertension, Respiratory Distress Syndrome
- What is being tested?
- iloprost
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- May 2006to Oct 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Elevated arterial pulmonary pressure
- GA > 24 GW
- 24-48 hours of age
- Ventilator treatment
Who cannot join
- Congenital anomalies
- Severe hypotension
Trial locations and contacts
1 site in 1 country.
Sweden1 site
University Hospital in Lund , Department of Pediatrics
Lund, Lund, 221 85
About this study
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.
- Being tested
- iloprost
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iloprostDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygenation index
Cardiac output
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2006
- Study completionOct 2008 (estimated)
Why it stopped: No patients enrolled after three years
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lund University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Investigators
- Vineta Fellman, Professor, Principal investigator, Lund University Hospital, Department of Pediatrics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00216931
- Sponsor's protocol ID
- 2004-001551-11
- Other IDs
- 2004
- Status last verified
- Feb 2009
- First submitted
- 15 Sep 2005
- Last updated
- 4 Feb 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Elevated Arterial Pulmonary Pressure With Inhaled Iloprost
- ClinicalTrials.gov ID
- NCT00216931
- Acronym / sponsor ID
- 2004-001551-11
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled after three years
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Lund University HospitalUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- May 2006
- Study completion
- Oct 2008 (estimated)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 24 to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Elevated arterial pulmonary pressure
- GA > 24 GW
- 24-48 hours of age
- Ventilator treatment
Key exclusion criteria (2 listed)
- Congenital anomalies
- Severe hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iloprost | Drug | – |
Primary outcome
Oxygenation index
Cardiac output
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vineta Fellman, Professor principal investigator
Lund University Hospital, Department of Pediatrics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iloprost in people with Persistent Pulmonary Hypertension and Respiratory Distress Syndrome, run by Lund University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygenation index. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2009.