Lung DiseasePhase 1/2NCT00041548
Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
A Phase 1/2 study testing nitric oxide for inhalation and Oxygen in people with Lung Disease and Hypoxemia, run by Mallinckrodt at 1 site in United States.
Trial summary
The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects. Read more about this study
- Who is it for?
- Ages Up to 120 hours
- Conditions the study is for
- Lung Disease, Hypoxemia, Respiratory Acidosis
- What is being tested?
- nitric oxide for inhalation and Oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- May 2002to Jun 2005
- Phase
- Phase 1/2
- 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 120 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age >34 completed weeks (>=35)
- Age <48 hours
- A-a DO2 400 to 600, on two post-ductal arterial blood gases one hour apart, while on 100% O2 by oxygen hood
- Post-ductal arterial access
- Admitted to The University of Alabama Birmingham Regional NICU
Who cannot join
- Cardiac disease (structural disease with right to left or mixing lesions), not including patent ductus arteriosus (PDA) or patent foramen ovale (PFO)
- Rapid deterioration requiring mechanical ventilation before entry into the study
- Major malformations
- Major neurologic or metabolic disorder or other illness leading to hypoventilation and hypercarbia
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Alabama Birmingham
Birmingham, Alabama, 35233
About this study
The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects.
Read the detailed description
It is possible that administration of inhaled NO to neonates with abnormal gas exchange earlier, rather than later as a rescue therapy in a moribund state, might accelerate the transition of the circulation from the fetal to neonatal physiology and improve oxygenation. This may in turn decrease the need for mechanical ventilation, its associated morbidity and perhaps even ECMO.
This study is designed as a pilot study to evaluate the physiologic efficacy (rather than effect on clinical outcomes) of NO administered by hood in improving oxygenation of neonates with elevated A-a DO2.
- Conditions
- Lung Disease, Hypoxemia, Respiratory Acidosis
- Being tested
- nitric oxide for inhalation, Oxygen
- Medical subject headings
- Lung Diseases, Hypoxia, Acidosis, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitric oxide for inhalationDrug
Also called INOmax
given at 20 ppm for 1 hour then weaned off over 4 hours
OxygenDrug
given at 20 ppm for one hour, then weaned off over four hours
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Nitric Oxide for Inhalation Receives: Drug: nitric oxide for inhalation |
| 2 | Placebo comparator | oxygen Receives: Drug: Oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2 level
Measured: at baseline, then every hour for 6 hours
Secondary outcomes (2)
Methemoglobin level
Measured: at baseline then every hour of treatment
Alveolar-arterial oxygen gradient and ratio
Measured: after 1 hour of treatment
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 startMay 2002
- Primary completionJun 2005
- Study completionJun 2005
Why it stopped: slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung DiseaseStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Waldemar Carlo, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00041548
- Sponsor's protocol ID
- CARLW1
- Status last verified
- Oct 2016
- First submitted
- 10 Jul 2002
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ambalavanan N, El-Ferzli GT, Roane C, Johnson R, Carlo WA. Nitric oxide administration using an oxygen hood: a pilot trial. PLoS One. 2009;4(2):e4312. doi: 10.1371/journal.pone.0004312. Epub 2009 Feb 2.
PubMed 19183804
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT00041548
- Acronym / sponsor ID
- CARLW1
- Conditions
- Lung Disease, Hypoxemia, Respiratory Acidosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment
- Enrolment
- 7 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (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 pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects.
Detailed description
It is possible that administration of inhaled NO to neonates with abnormal gas exchange earlier, rather than later as a rescue therapy in a moribund state, might accelerate the transition of the circulation from the fetal to neonatal physiology and improve oxygenation. This may in turn decrease the need for mechanical ventilation, its associated morbidity and perhaps even ECMO.
This study is designed as a pilot study to evaluate the physiologic efficacy (rather than effect on clinical outcomes) of NO administered by hood in improving oxygenation of neonates with elevated A-a DO2.
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 | Experimental | Drug: nitric oxide for inhalationNitric Oxide for Inhalation |
| 2 | Placebo comparator | Drug: Oxygenoxygen |
Who may qualify
- Ages
- Up to 120 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age >34 completed weeks (>=35)
- Age <48 hours
- A-a DO2 400 to 600, on two post-ductal arterial blood gases one hour apart, while on 100% O2 by oxygen hood
- Post-ductal arterial access
- Admitted to The University of Alabama Birmingham Regional NICU
Key exclusion criteria (4 listed)
- Cardiac disease (structural disease with right to left or mixing lesions), not including patent ductus arteriosus (PDA) or patent foramen ovale (PFO)
- Rapid deterioration requiring mechanical ventilation before entry into the study
- Major malformations
- Major neurologic or metabolic disorder or other illness leading to hypoventilation and hypercarbia
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 |
|---|---|---|
| nitric oxide for inhalationAlso: INOmaxgiven at 20 ppm for 1 hour then weaned off over 4 hours | Drug | 1 |
| Oxygengiven at 20 ppm for one hour, then weaned off over four hours | Drug | 2 |
Primary outcome
PaO2 level
Time frame: at baseline, then every hour for 6 hours
2 secondary outcomes
Methemoglobin level
Time frame: at baseline then every hour of treatment
Alveolar-arterial oxygen gradient and ratio
Time frame: after 1 hour of treatment
Results and safety
The study was stopped early (reason given: slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
- Derived from this study: PubMed 19183804Ambalavanan N, El-Ferzli GT, Roane C, Johnson R, Carlo WA. Nitric oxide administration using an oxygen hood: a pilot trial. PLoS One. 2009;4(2):e4312. doi: 10.1371/journal.pone.0004312. Epub 2009 Feb 2.
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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.
Waldemar Carlo, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing nitric oxide for inhalation and Oxygen in people with Lung Disease and Hypoxemia, run by Mallinckrodt 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 5 inclusion and 4 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 19 Oct 2016. 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. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: slow 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?
PaO2 level (time frame: at baseline, then every hour for 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00041548, which also lists 1 linked publication.
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 Oct 2016.