Respiratory InsufficiencyPhase 3NCT00041561
Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) in Pediatrics
A Phase 3 study testing Nitrogen gas and inhaled nitric oxide in people with Respiratory Insufficiency and Anoxemia, run by Mallinckrodt at 16 sites in United States.
Trial summary
The purpose of this study is to determine the effect of nitric oxide for inhalation on the duration of mechanical ventilation in pediatric patients with AHRF. Read more about this study
- Who is it for?
- Ages Up to 16 years
- Conditions the study is for
- Respiratory Insufficiency, Anoxemia
- What is being tested?
- Nitrogen gas and inhaled nitric oxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 16 sitesUnited States
- Study dates
- Jan 2002to Dec 2004
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admitted to pediatric intensive care unit and have the diagnosis of acute respiratory failure
- 44 weeks post conceptional age to 16 years of age
- Oxygenation Index (OI) >=12 cm H2O/mmHg (as determined by two separate measurement taken 30 minutes to 4 hours apart)
- Recent chest x-ray (within 24 hours) showing at least unilateral infiltrations
- Mechanically ventilated <= 7 days
Who cannot join
- Immunocompromised
- Received a bone marrow transplant
- Active oncological condition
- Persistent right to left intracardiac shunt
- Cardiovascular surgery within the last 14 days
- Status asthmaticus
Show all 10Show fewer
- Decision by primary care physician not to provide full support
- Received treatment with nitric oxide for inhalation or other investigational medications within 24 hours prior to study initiation, participating in surfactant trials
- Chronically ventilated
- Pregnant
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
The Medical University of South Carolina
Charleston, South Carolina, 29425
University of Virginia Pediatric Critical Care
Charlottesville, Virginia, 22908
University of Chicago, Children's Hospital
Chicago, Illinois, 60637
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Children's Hospital
Columbus, Ohio, 43205
The Children's Hospital
Denver, Colorado, 80218
New York Presbyterian Hospital
New York, New York, 10021
Chrildren's Hospital of Orange County
Orange, California, 92868
Nemours Children's Clinic
Orlando, Florida, 32806
Oregon Health and Science University
Portland, Oregon, 97239
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71103
Stanford University Medical Center
Stanford, California, 94305
Children's Hospital at Montefiore
The Bronx, New York, 10467
About this study
Official title: The Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) In Pediatrics
The purpose of this study is to determine the effect of nitric oxide for inhalation on the duration of mechanical ventilation in pediatric patients with AHRF.
Read the detailed description
Patients will receive 5-ppm study gas (nitric oxide for inhalation or placebo) until Day 28 or extubation, whichever comes first. The following will be performed / recorded at specified times during the study: arterial blood gases, ventilator settings, methemoglobin, PRISM III score, and patient positioning. Selected centers will also be performing plasma cytokine assays, broncho-alveolar lavage fluid assays and a 6 month follow-up assessment.
- Conditions
- Respiratory Insufficiency, Anoxemia
- Being tested
- Nitrogen gas, inhaled nitric oxide
- Keywords
- Acute hypoxemic respiratory failure
- Medical subject headings
- Respiratory Insufficiency, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nitrogen gasDrug
Nitrogen gas will be given at 5ppm until Day 28 or extubation
inhaled nitric oxideDrug
Also called INOmax®
inhaled nitric oxide will be given at 5 ppm until day 28 or extubation
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Nitrogen gas Receives: Drug: Nitrogen gas |
| 1 | Experimental | Inhaled Nitric Oxide Receives: Drug: inhaled nitric oxide |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial blood gases
Measured: baseline through 24 hours and extubation
Secondary outcomes (3)
methemoglobin
Measured: baseline, hour 4 and 24 hours
broncho-alveolar lavage fluid
Measured: baseline, 48 hours and day 5
Prone position
Measured: baseline then daily
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2002 (estimated)
- Study startJan 2002
- Primary completionDec 2004
- Study completionDec 2004
Why it stopped: Study stopped due to poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Baldassarre, MD, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041561
- Sponsor's protocol ID
- INOT-11
- Status last verified
- Jul 2016
- First submitted
- 10 Jul 2002
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inhaled Nitric Oxide in the Treatment of Acute Hypoxemic Respiratory Failure (AHRF) In Pediatrics
- ClinicalTrials.gov ID
- NCT00041561
- Acronym / sponsor ID
- INOT-11
- Conditions
- Respiratory Insufficiency, Anoxemia
- Keywords
- Acute hypoxemic respiratory failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to poor enrollment
- Enrolment
- 55 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Jan 2002
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 11 Jul 2002 (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 the effect of nitric oxide for inhalation on the duration of mechanical ventilation in pediatric patients with AHRF.
Detailed description
Patients will receive 5-ppm study gas (nitric oxide for inhalation or placebo) until Day 28 or extubation, whichever comes first. The following will be performed / recorded at specified times during the study: arterial blood gases, ventilator settings, methemoglobin, PRISM III score, and patient positioning. Selected centers will also be performing plasma cytokine assays, broncho-alveolar lavage fluid assays and a 6 month follow-up assessment.
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 |
|---|---|---|
| 2 | Placebo comparator | Drug: Nitrogen gasNitrogen gas |
| 1 | Experimental | Drug: inhaled nitric oxideInhaled Nitric Oxide |
Who may qualify
- Ages
- Up to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Admitted to pediatric intensive care unit and have the diagnosis of acute respiratory failure
- 44 weeks post conceptional age to 16 years of age
- Oxygenation Index (OI) >=12 cm H2O/mmHg (as determined by two separate measurement taken 30 minutes to 4 hours apart)
- Recent chest x-ray (within 24 hours) showing at least unilateral infiltrations
- Mechanically ventilated <= 7 days
Key exclusion criteria (10 listed)
- Immunocompromised
- Received a bone marrow transplant
- Active oncological condition
- Persistent right to left intracardiac shunt
- Cardiovascular surgery within the last 14 days
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 |
|---|---|---|
| Nitrogen gasNitrogen gas will be given at 5ppm until Day 28 or extubation | Drug | 2 |
| inhaled nitric oxideAlso: INOmax®inhaled nitric oxide will be given at 5 ppm until day 28 or extubation | Drug | 1 |
Primary outcome
arterial blood gases
Time frame: baseline through 24 hours and extubation
3 secondary outcomes
methemoglobin
Time frame: baseline, hour 4 and 24 hours
broncho-alveolar lavage fluid
Time frame: baseline, 48 hours and day 5
Prone position
Time frame: baseline then daily
Results and safety
The study was stopped early (reason given: Study stopped due to poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
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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.
James Baldassarre, MD study director
Mallinckrodt
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nitrogen gas and inhaled nitric oxide in people with Respiratory Insufficiency and Anoxemia, run by Mallinckrodt at 16 sites 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites 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. 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 was stopped early (reason given: Study stopped due to poor enrollment). Results are not available in the source record.
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?
arterial blood gases (time frame: baseline through 24 hours and extubation). 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 26 Jul 2016.