Respiratory FailurePhase 4NCT00732537
Inhaled Nitric Oxide by Oxygen Hood in Neonates
A Phase 4 study testing inhaled Nitric Oxide and Oxygen (>90% by hood) - standard therapy in people with Respiratory Failure and Infant, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Inhaled nitric oxide (iNO) improves oxygenation in term infants with respiratory failure. However, iNO has been primarily used in infants receiving mechanical ventilation. This study is a pilot study to determine if iNO given into an oxygen hood is effective in improving oxygenation in term and near-term infants who… Read more about this study
- Who is it for?
- Ages 1 hour to 1 week
- Conditions the study is for
- Respiratory Failure, Infant, Persistent Fetal Circulation
- What is being tested?
- inhaled Nitric Oxide and Oxygen (>90% by hood) - standard therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 1999to Jun 2005
- Phase
- Phase 4
- 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 1 hour to 1 week
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- gestation >34 weeks at birth
- age <7 days
- post-ductal arterial line
- an A-aDO2 of 400 to 600 on two blood gases, at least 30 minutes apart.
Who cannot join
- Infants with major malformations
- Infants with cardiac disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Regional Neonatal ICU, University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: Inhaled Nitric Oxide in Neonates With Elevated A-aDO2 Gradients Not Requiring Mechanical Ventilation
Inhaled nitric oxide (iNO) improves oxygenation in term infants with respiratory failure. However, iNO has been primarily used in infants receiving mechanical ventilation. This study is a pilot study to determine if iNO given into an oxygen hood is effective in improving oxygenation in term and near-term infants who have poor oxygenation but who are not yet mechanically ventilated.
Read the detailed description
Inhaled nitric oxide (iNO) is currently used in the management of ventilated neonates with hypoxemic respiratory failure. We have shown that iNO administered by oxygen hood reduces pulmonary vascular resistance in hypoxia- and group B streptococcus-induced pulmonary hypertension in an animal model (J Perinatol 2002; 22:50-6). Our objective was to determine the feasibility of iNO administration by oxygen hood in neonates with respiratory failure. Methods: A masked randomized controlled trial was performed on eight infants with respiratory failure. Inclusion criteria were: gestation>34 weeks, age<7 days, with post-ductal arterial line, and A-aDO2 400-600 on two consecutive blood gases. Infants were randomized to study gas (iNO at 20 ppm or equivalent flow of O2) for 1 hr which was then weaned over the next 4 hours. The iNO was introduced into an oxygen hood using an INOvent (INO Therapeutics, Inc). The primary outcome was the PaO2 one hour after randomization. Environmental leakage of NO and NO2 were measured. Results: Four infants were randomized to iNO and four to O2 (controls). Two of the four infants given iNO had an increase in PaO2 of >100 mm Hg, while oxygenation was unchanged in the controls. Methemoglobinemia and other adverse effects were not noted in any infant. Environmental levels of NO and NO2 were minimal (<1ppm) to undetectable at >0.3m from the hood. Conclusions: Administration of iNO by oxygen hood is feasible. Larger randomized controlled trials are required to measure the efficacy and determine an appropriate target population for this technique.
- Conditions
- Respiratory Failure, Infant, Persistent Fetal Circulation
- Being tested
- inhaled Nitric Oxide, Oxygen (>90% by hood) - standard therapy
- Keywords
- Hypoxia, Respiratory failure, Infant, term, Nitric oxide
- Medical subject headings
- Respiratory Insufficiency, Persistent Fetal Circulation Syndrome, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inhaled Nitric OxideDrug
Also called iNO, Nitric Oxide
iNO started at 20 ppm for 1 hour, then weaned hourly over the next 4 hours (20 ppm to 10 to 5 to 2.5 to 1 to off). If >5% drop in oxygen saturation was observed during weaning, study gas was increased to the previous concentration and weaning done 2 hourly. If > 5% drop in oxygen saturation or >5% Methemoglobin was observed during initial administration, the study gas would be weaned over 30 minutes and the infant would exit. The iNO was introduced into an oxygen hood (Oxydome ™ disposable hood from Maxtex ® Inc.) using an INOvent (Datex-Ohmeda). The INOvent ® was connected to the oxyhood by placing the injector module inline on the dry side of the humidifier chamber. Monitoring of O2, NO2, NO was done by placing the end of the sample line inside the oxyhood. A "Masking Shield" covered the Display/Control Panel and Cylinder Gauges, in order to maintain masking of the intervention. Only the respiratory therapist and research coordinator was aware of the allocation assignment.
Oxygen (>90% by hood) - standard therapyDrug
Also called Oxygen, Head box
Oxygen (>90% by hood, standard therapy for PPHN prior to intubation) was introduced into an oxygen hood (Oxydome ™ disposable hood from Maxtex ® Inc.) using an INOvent (Datex-Ohmeda). The INOvent ® was connected to the oxyhood by placing the injector module inline on the dry side of the humidifier chamber. If the baby was randomized to the control group and did not receive NO, the INOmax® cylinder was opened and used only to pressurize the system, which prevented the "Low NO Pressure" alarm. A "Masking Shield" covered the Display/Control Panel and Cylinder Gauges, in order to maintain masking of the intervention. Only the respiratory therapist and research coordinator was aware of the allocation assignment.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Nitric Oxide | Experimental | iNO started at 20 ppm for 1 hour. The gas was then weaned hourly over the next 4 hours (20 ppm to 10 to 5 to 2.5 to 1 to off). Receives: Drug: inhaled Nitric Oxide |
| Placebo | Placebo comparator | The Oxygen at high concentration (>90%), which was standard therapy for PPHN, was introduced into an oxygen hood (Oxydome ™ disposable hood from Maxtex ® Inc.) using an INOvent (Datex-Ohmeda). Receives: Drug: Oxygen (>90% by hood) - standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PaO2 one hour after the first hour of study gas
Measured: one hour after the first hour of study gas
Secondary outcomes (8)
Alveolar-arterial oxygen gradient (A-a DO2)
Measured: one hour of exposure to treatment gas
oxygen saturation by pulse oximetry (SpO2)
Measured: continuously through the study
need for mechanical ventilation
Measured: Continuously through the study
duration of oxygen therapy
Measured: continuously through the study
Methemoglobin level in post-ductal arterial blood (MetHb)
Measured: Hourly until completion of study in infant
Platelet count
Measured: As needed if bleeding
Systemic blood pressure
Measured: hourly
Environmental NO and NO2 exposure
Measured: Hourly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2008 (estimated)
- Study startMar 1999
- Primary completionJun 2005
- Study completionJun 2005
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 Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Investigators
- Namasivayam Ambalavanan, MD, Principal investigator, University of Alabama at BirminghamWaldemar A Carlo, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732537
- Sponsor's protocol ID
- F990225003
- Status last verified
- Aug 2008
- First submitted
- 8 Aug 2008
- Last updated
- 12 Aug 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Ambalavanan N, St John E, Carlo WA, Bulger A, Philips JB 3rd. Feasibility of nitric oxide administration by oxygen hood in neonatal pulmonary hypertension. J Perinatol. 2002 Jan;22(1):50-6. doi: 10.1038/sj.jp.7210652.
PubMed 11840243
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Nitric Oxide in Neonates With Elevated A-aDO2 Gradients Not Requiring Mechanical Ventilation
- ClinicalTrials.gov ID
- NCT00732537
- Acronym / sponsor ID
- F990225003
- Conditions
- Respiratory Failure, Infant, Persistent Fetal Circulation
- Keywords
- Hypoxia, Respiratory failure, Infant, term, Nitric oxide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Mar 1999
- Primary completion
- Jun 2005 (actual)
- Study completion
- Jun 2005 (actual)
- First posted
- 12 Aug 2008 (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.
Inhaled nitric oxide (iNO) improves oxygenation in term infants with respiratory failure. However, iNO has been primarily used in infants receiving mechanical ventilation. This study is a pilot study to determine if iNO given into an oxygen hood is effective in improving oxygenation in term and near-term infants who have poor oxygenation but who are not yet mechanically ventilated.
Detailed description
Inhaled nitric oxide (iNO) is currently used in the management of ventilated neonates with hypoxemic respiratory failure. We have shown that iNO administered by oxygen hood reduces pulmonary vascular resistance in hypoxia- and group B streptococcus-induced pulmonary hypertension in an animal model (J Perinatol 2002; 22:50-6). Our objective was to determine the feasibility of iNO administration by oxygen hood in neonates with respiratory failure. Methods: A masked randomized controlled trial was performed on eight infants with respiratory failure. Inclusion criteria were: gestation>34 weeks, age<7 days, with post-ductal arterial line, and A-aDO2 400-600 on two consecutive blood gases. Infants were randomized to study gas (iNO at 20 ppm or equivalent flow of O2) for 1 hr which was then weaned over the next 4 hours. The iNO was introduced into an oxygen hood using an INOvent (INO Therapeutics, Inc). The primary outcome was the PaO2 one hour after randomization. Environmental leakage of NO and NO2 were measured. Results: Four infants were randomized to iNO and four to O2 (controls). Two of the four infants given iNO had an increase in PaO2 of >100 mm Hg, while oxygenation was unchanged in the controls. Methemoglobinemia and other adverse effects were not noted in any infant. Environmental levels of NO and NO2 were minimal (<1ppm) to undetectable at >0.3m from the hood. Conclusions: Administration of iNO by oxygen hood is feasible. Larger randomized controlled trials are required to measure the efficacy and determine an appropriate target population for this technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Nitric Oxide | Experimental | Drug: inhaled Nitric OxideiNO started at 20 ppm for 1 hour. The gas was then weaned hourly over the next 4 hours (20 ppm to 10 to 5 to 2.5 to 1 to off). |
| Placebo | Placebo comparator | Drug: Oxygen (>90% by hood) - standard therapyThe Oxygen at high concentration (>90%), which was standard therapy for PPHN, was introduced into an oxygen hood (Oxydome ™ disposable hood from Maxtex ® Inc.) using an INOvent (Datex-Ohmeda). |
Who may qualify
- Ages
- 1 hour to 1 week
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- gestation >34 weeks at birth
- age <7 days
- post-ductal arterial line
- an A-aDO2 of 400 to 600 on two blood gases, at least 30 minutes apart.
Key exclusion criteria (2 listed)
- Infants with major malformations
- Infants with cardiac disease
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 OxideAlso: iNO, Nitric OxideiNO started at 20 ppm for 1 hour, then weaned hourly over the next 4 hours (20 ppm to 10 to 5 to 2.5 to 1 to off). If >5% drop in oxygen saturation was observed during weaning, study gas was increased to the previous concentration and weaning done 2 hourly. If > 5% drop in oxygen saturation or >5% Methemoglobin was observed during initial administration, the study gas would be weaned over 30 minutes and the infant would exit. The iNO was introduced into an oxygen hood (Oxydome ™ disposable hood from Maxtex ® Inc.) using an INOvent (Datex-Ohmeda). The INOvent ® was connected to the oxyhood by placing the injector module inline on the dry side of the humidifier chamber. Monitoring of O2, NO2, NO was done by placing the end of the sample line inside the oxyhood. A "Masking Shield" covered the Display/Control Panel and Cylinder Gauges, in order to maintain masking of the intervention. Only the respiratory therapist and research coordinator was aware of the allocation assignment. | Drug | Inhaled Nitric Oxide |
| Oxygen (>90% by hood) - standard therapyAlso: Oxygen, Head boxOxygen (>90% by hood, standard therapy for PPHN prior to intubation) was introduced into an oxygen hood (Oxydome ™ disposable hood from Maxtex ® Inc.) using an INOvent (Datex-Ohmeda). The INOvent ® was connected to the oxyhood by placing the injector module inline on the dry side of the humidifier chamber. If the baby was randomized to the control group and did not receive NO, the INOmax® cylinder was opened and used only to pressurize the system, which prevented the "Low NO Pressure" alarm. A "Masking Shield" covered the Display/Control Panel and Cylinder Gauges, in order to maintain masking of the intervention. Only the respiratory therapist and research coordinator was aware of the allocation assignment. | Drug | Placebo |
Primary outcome
PaO2 one hour after the first hour of study gas
Time frame: one hour after the first hour of study gas
8 secondary outcomes
Alveolar-arterial oxygen gradient (A-a DO2)
Time frame: one hour of exposure to treatment gas
oxygen saturation by pulse oximetry (SpO2)
Time frame: continuously through the study
need for mechanical ventilation
Time frame: Continuously through the study
duration of oxygen therapy
Time frame: continuously through the study
Methemoglobin level in post-ductal arterial blood (MetHb)
Time frame: Hourly until completion of study in infant
Platelet count
Time frame: As needed if bleeding
Systemic blood pressure
Time frame: hourly
Environmental NO and NO2 exposure
Time frame: Hourly
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 12 Aug 2008.
- Background: PubMed 11840243Ambalavanan N, St John E, Carlo WA, Bulger A, Philips JB 3rd. Feasibility of nitric oxide administration by oxygen hood in neonatal pulmonary hypertension. J Perinatol. 2002 Jan;22(1):50-6. doi: 10.1038/sj.jp.7210652.
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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.
Namasivayam Ambalavanan, MD principal investigator
University of Alabama at Birmingham
Waldemar A 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 4 study testing inhaled Nitric Oxide and Oxygen (>90% by hood) - standard therapy in people with Respiratory Failure and Infant, run by University of Alabama at Birmingham 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 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: finished, as of the sponsor's last update on 12 Aug 2008. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
PaO2 one hour after the first hour of study gas (time frame: one hour after the first hour of study gas). 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 NCT00732537, 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 12 Aug 2008.