Congenital Heart DefectPhase 2/3NCT00945529
The Effects of Inhaled Nitric Oxide After Fontan Operation
A Phase 2/3 study testing inhaled nitric oxide (iNO) in people with Congenital Heart Defect, run by Ellen Spurrier at 1 site in United States.
Trial summary
Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Congenital Heart Defect
- What is being tested?
- inhaled nitric oxide (iNO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2011
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male/female patients
- Undergoing Fontan operation at the Nemours Cardiac Center at A. I. duPont Hospital for Children
- Written parental permission to participate in this research study
Who cannot join
- Any condition which the PI feels will interfere with the patient's safe and effective participation
Trial locations and contacts
1 site in 1 country.
United States1 site
A. I. duPont Hospital for Children/Nemours Cardiac Center
Wilmington, Delaware, 19803
About this study
Official title: The Effects of Inhaled Nitric Oxide on Patient Morbidity and Length of Hospital Stay Following Fontan Operation
Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance. The study hypothesis is that inhaled nitric oxide after Fontan operation will improve fluid balance, thus decreasing the incidence of pleural effusions and shortening hospital stay.
- Conditions
- Congenital Heart Defect
- Being tested
- inhaled nitric oxide (iNO)
- Keywords
- Fontan
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled nitric oxide (iNO)Drug
Also called Inomax
Inhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention/ historical control group | No intervention | historical controls group of patients who did not receive iNO. |
| Intervention | Experimental | Prospective group who received iNO. Receives: Drug: inhaled nitric oxide (iNO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospital Stay Following Fontan
Measured: until hospital discharge
Secondary outcomes (1)
Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage
Percent of patients with significant pleural fluid collections that required thoracostomy drainage
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startFeb 2008
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Congenital Heart DefectStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ellen Spurrier
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor-investigator, Ellen Spurrier, Nemours Children's Clinic
- Investigators
- Ellen Spurrier, MD, Principal investigator, Nemours Children's Clinic - A. I. duPont Hospital for Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945529
- Sponsor's protocol ID
- SPURE1
- Status last verified
- Apr 2023
- First submitted
- 28 May 2009
- Last updated
- 19 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inhaled Nitric Oxide on Patient Morbidity and Length of Hospital Stay Following Fontan Operation
- ClinicalTrials.gov ID
- NCT00945529
- Acronym / sponsor ID
- SPURE1
- Conditions
- Congenital Heart Defect
- Keywords
- Fontan
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ellen SpurrierUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Feb 2008
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Jul 2009 (estimated)
- Results
- Posted 19 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance. The study hypothesis is that inhaled nitric oxide after Fontan operation will improve fluid balance, thus decreasing the incidence of pleural effusions and shortening hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Intervention/ historical control group | No intervention | –historical controls group of patients who did not receive iNO. |
| Intervention | Experimental | Drug: inhaled nitric oxide (iNO)Prospective group who received iNO. |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Male/female patients
- Undergoing Fontan operation at the Nemours Cardiac Center at A. I. duPont Hospital for Children
- Written parental permission to participate in this research study
Key exclusion criteria (1 listed)
- Any condition which the PI feels will interfere with the patient's safe and effective participation
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 |
|---|---|---|
| inhaled nitric oxide (iNO)Also: InomaxInhaled nitric oxide 40ppm for 48 hours followed by a 6-hour wean. | Drug | Intervention |
Primary outcome
Length of Hospital Stay Following Fontan
Time frame: until hospital discharge
1 secondary outcome
Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage
Time frame: 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Ellen Spurrier, MD principal investigator
Nemours Children's Clinic - A. I. duPont Hospital for Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing inhaled nitric oxide (iNO) in people with Congenital Heart Defect, run by Ellen Spurrier at 1 site in United States.
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 3 inclusion and 1 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 19 May 2023. 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 United States. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Yes. Results are posted in the registry (first posted 19 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Hospital Stay Following Fontan (time frame: until hospital discharge). 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 19 May 2023.