Lung DiseasesPhase 3NCT00431418
The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease
A Phase 3 study testing Sildenafil in people with Lung Diseases, run by Mercy Hospital for Women, Australia at 1 site in Australia.
Trial summary
The purpose of this pilot study is to investigate in a randomised double-blind trial whether treatment with Sildenafil reduces duration of ventilatory support in preterm infants born at 28 weeks of gestation or less. Read more about this study
- Who is it for?
- Ages Up to 7 days
- Conditions the study is for
- Lung Diseases
- What is being tested?
- Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- Jan 2007to Jun 2012
- Phase
- Phase 3
- 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 Up to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn babies born <28 weeks of gestation who still need ventilatory support via endotracheal tube or have been re-ventilated at day 7 of life.
Who cannot join
- Congenital heart defects
- Suspected inborn error of metabolism
- Inhaled Nitric Oxide treatment during assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease (SPICE Trial): a Pilot Study
The purpose of this pilot study is to investigate in a randomised double-blind trial whether treatment with Sildenafil reduces duration of ventilatory support in preterm infants born at 28 weeks of gestation or less.
- Conditions
- Lung Diseases
- Being tested
- Sildenafil, Placebo
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Revatio(R)
Sildenafil oral solution
PlaceboDrug
Placebo solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Sildenafil oral solution. Receives: Drug: Sildenafil |
| 2 | Placebo comparator | Placebo oral solution. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of ventilation
Measured: 12 months after completion of study
Secondary outcomes (1)
Bronchopulmonary Dysplasia (BPD)
Measured: 12 months after completion of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2007 (estimated)
- Study startJan 2007
- Primary completionJul 2010
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Hospital for Women, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Kai Konig, Mercy Hospital for Women, Australia
- Investigators
- Kai König, MD, Principal investigator, Mercy Hospital for WomenCharles P Barfield, MD, Principal investigator, Mercy Hospital for WomenChad C Andersen, MD, Principal investigator, Mercy Hospital for Women
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00431418
- Sponsor's protocol ID
- R 06/34
- Status last verified
- Sep 2015
- First submitted
- 2 Feb 2007
- Last updated
- 23 Sep 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sildenafil in Preterm Infants With Evolving Chronic Lung Disease (SPICE Trial): a Pilot Study
- ClinicalTrials.gov ID
- NCT00431418
- Acronym / sponsor ID
- R 06/34
- Conditions
- Lung Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mercy Hospital for Women, AustraliaUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Feb 2007 (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 pilot study is to investigate in a randomised double-blind trial whether treatment with Sildenafil reduces duration of ventilatory support in preterm infants born at 28 weeks of gestation or less.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: SildenafilSildenafil oral solution. |
| 2 | Placebo comparator | Drug: PlaceboPlacebo oral solution. |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Newborn babies born <28 weeks of gestation who still need ventilatory support via endotracheal tube or have been re-ventilated at day 7 of life.
Key exclusion criteria (3 listed)
- Congenital heart defects
- Suspected inborn error of metabolism
- Inhaled Nitric Oxide treatment during assessment
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 |
|---|---|---|
| SildenafilAlso: Revatio(R)Sildenafil oral solution | Drug | 1 |
| PlaceboPlacebo solution | Drug | 2 |
Primary outcome
Length of ventilation
Time frame: 12 months after completion of study
1 secondary outcome
Bronchopulmonary Dysplasia (BPD)
Time frame: 12 months after completion of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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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.
Kai König, MD principal investigator
Mercy Hospital for Women
Charles P Barfield, MD principal investigator
Mercy Hospital for Women
Chad C Andersen, MD principal investigator
Mercy Hospital for Women
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sildenafil in people with Lung Diseases, run by Mercy Hospital for Women, Australia at 1 site in Australia.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 23 Sep 2015. 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 Australia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Length of ventilation (time frame: 12 months after completion of study). 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 23 Sep 2015.