Hypoxic Respiratory Failure With Pulmonary HypertensionPhase 3NCT00922532
Inhaled Nitric Oxide (INO) In Hypoxic Respiratory Failure
A Phase 3 study testing Inhaled Nitric Oxide in people with Hypoxic Respiratory Failure With Pulmonary Hypertension, run by Mallinckrodt.
Trial summary
This Phase 3, Double-blind, Randomized, Placebo controlled, multicenter study is to confirm the efficacy of inhaled nitric oxide for the management of hypoxic respiratory failure associated with pulmonary hypertension in preterm infants. Read more about this study
- Who is it for?
- Ages Up to 48 hours
- Conditions the study is for
- Hypoxic Respiratory Failure With Pulmonary Hypertension
- What is being tested?
- Inhaled Nitric Oxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2009to Oct 2011
- 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 48 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants who:
- Are in-born at < 30 weeks gestational age
- Weigh 500-1250 grams
- Have hypoxic respiratory failure requiring mechanical ventilation with FiO2 > 0.8 to maintain SaO2 ≥ 85% in the first 48 hours after birth after use of exogenous surfactant
- Have minimal parenchymal lung disease by chest X ray
Who cannot join
- Preterm infants who:
- Have ten minute Apgar score < 5
- Have life-threatening anomalies (cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any child who will not receive complete intensive care
- Have bilateral Grade IV Intraventricular Hemorrhage (IVH)
- Are dependent on right to left shunting to maintain the systemic circulation
- Have received prior iNO therapy
- Have had treatment with investigational medications
About this study
Official title: Inhaled Nitric Oxide For The Treatment Of Hypoxic Respiratory Failure With Pulmonary Hypertension In Preterm Infants
This Phase 3, Double-blind, Randomized, Placebo controlled, multicenter study is to confirm the efficacy of inhaled nitric oxide for the management of hypoxic respiratory failure associated with pulmonary hypertension in preterm infants.
Study subjects will be administered either inhaled nitric oxide or placebo to determine if there is a change in oxygenation.
Read the detailed description
This trial will be a multi-center, double blind, placebo-controlled, randomized clinical trial. All mothers identified with prolonged rupture of membranes and/or oligohydramnios, and all inborn infants < 30 weeks gestational age (GA) at birth will be screened for enrollment. Infants who meet all inclusion and exclusion criteria within the first 48 hours after birth will be randomized to either inhaled NO starting at 20 ppm, or matched placebo, delivered by means of a blinded INOvent® delivery device. Randomization will be stratified by center and treatment will be assigned using an interactive voice or web-based response system (IVRS). All infants will receive up to 14 days of therapy, following a dose reduction schedule. The primary outcome measure will be change in oxygenation at 1 hour after start of therapy. In order to determine the effects of iNO therapy on survival and need for mechanical ventilation, cross-over will not be allowed.
This clinical trial will attempt to demonstrate if pre-term infants may benefit from treatment with nitric oxide for inhalation. A multi-center study is necessary to recruit an appropriate number of subjects, and to reflect the variability of standard practice across the different participating centers. All treatment assignments are blinded in order to minimize the risk of bias in treatment and data collection. In addition, a concurrent placebo group has been chosen as the most appropriate control group since there may be temporal, institutional and national variations in average outcomes. Methemoglobin levels will be measured locally and will collected in a blinded manner.
- Being tested
- Inhaled Nitric Oxide, Placebo
- Keywords
- Hypoxic Respiratory Failure (HRF), Pulmonary Hypertension
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled Nitric OxideDrug
Also called INOmax
Inhaled Nitric Oxide will be administered continuously starting at 20ppm through an INOvent delivery system for up to 14 days.
PlaceboDrug
Nitrogen gas will be administered in the same manor as the experimental drug
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Nitric Oxide | Experimental | Inhaled Nitric Oxide Receives: Drug: Inhaled Nitric Oxide |
| Nitrogen | Placebo comparator | Nitrogen Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial Blood Gases
Measured: Day 1 through Day 6
Secondary outcomes (4)
Methemoglobin levels
Measured: Treatment Duration
Vital Signs
Measured: Study Duration
Adverse Events
Measured: Study Duration
cGMP Levels
Measured: Day 1 through 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2011 (estimated)
- Study completionOct 2011 (estimated)
Why it stopped: Company decision not to pursue prior to submission
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoxic Respiratory Failure With Pulmonary HypertensionStudies 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00922532
- Sponsor's protocol ID
- IK-3001-HRF-301
- Status last verified
- Sep 2016
- First submitted
- 16 Jun 2009
- Last updated
- 9 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Nitric Oxide For The Treatment Of Hypoxic Respiratory Failure With Pulmonary Hypertension In Preterm Infants
- ClinicalTrials.gov ID
- NCT00922532
- Acronym / sponsor ID
- IK-3001-HRF-301
- Keywords
- Hypoxic Respiratory Failure (HRF), Pulmonary Hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company decision not to pursue prior to submission
- Enrolment
- 0 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Oct 2011 (estimated)
- First posted
- 17 Jun 2009 (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.
This Phase 3, Double-blind, Randomized, Placebo controlled, multicenter study is to confirm the efficacy of inhaled nitric oxide for the management of hypoxic respiratory failure associated with pulmonary hypertension in preterm infants.
Study subjects will be administered either inhaled nitric oxide or placebo to determine if there is a change in oxygenation.
Detailed description
This trial will be a multi-center, double blind, placebo-controlled, randomized clinical trial. All mothers identified with prolonged rupture of membranes and/or oligohydramnios, and all inborn infants < 30 weeks gestational age (GA) at birth will be screened for enrollment. Infants who meet all inclusion and exclusion criteria within the first 48 hours after birth will be randomized to either inhaled NO starting at 20 ppm, or matched placebo, delivered by means of a blinded INOvent® delivery device. Randomization will be stratified by center and treatment will be assigned using an interactive voice or web-based response system (IVRS). All infants will receive up to 14 days of therapy, following a dose reduction schedule. The primary outcome measure will be change in oxygenation at 1 hour after start of therapy. In order to determine the effects of iNO therapy on survival and need for mechanical ventilation, cross-over will not be allowed.
This clinical trial will attempt to demonstrate if pre-term infants may benefit from treatment with nitric oxide for inhalation. A multi-center study is necessary to recruit an appropriate number of subjects, and to reflect the variability of standard practice across the different participating centers. All treatment assignments are blinded in order to minimize the risk of bias in treatment and data collection. In addition, a concurrent placebo group has been chosen as the most appropriate control group since there may be temporal, institutional and national variations in average outcomes. Methemoglobin levels will be measured locally and will collected in a blinded manner.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Nitric Oxide | Experimental | Drug: Inhaled Nitric OxideInhaled Nitric Oxide |
| Nitrogen | Placebo comparator | Drug: PlaceboNitrogen Placebo |
Who may qualify
- Ages
- Up to 48 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Are in-born at < 30 weeks gestational age
- Weigh 500-1250 grams
- Have hypoxic respiratory failure requiring mechanical ventilation with FiO2 > 0.8 to maintain SaO2 ≥ 85% in the first 48 hours after birth after use of exogenous surfactant
- Have minimal parenchymal lung disease by chest X ray
Key exclusion criteria (7 listed)
- Have ten minute Apgar score < 5
- Have life-threatening anomalies (cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any child who will not receive complete intensive care
- Have bilateral Grade IV Intraventricular Hemorrhage (IVH)
- Are dependent on right to left shunting to maintain the systemic circulation
- Have received prior iNO therapy
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: INOmaxInhaled Nitric Oxide will be administered continuously starting at 20ppm through an INOvent delivery system for up to 14 days. | Drug | Inhaled Nitric Oxide |
| PlaceboNitrogen gas will be administered in the same manor as the experimental drug | Drug | Nitrogen |
Primary outcome
Arterial Blood Gases
Time frame: Day 1 through Day 6
4 secondary outcomes
Methemoglobin levels
Time frame: Treatment Duration
Vital Signs
Time frame: Study Duration
Adverse Events
Time frame: Study Duration
cGMP Levels
Time frame: Day 1 through 14
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inhaled Nitric Oxide in people with Hypoxic Respiratory Failure With Pulmonary Hypertension, run by Mallinckrodt.
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 7 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: withdrawn, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 withdrawn before enrolling participants, so there are no results.
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: Day 1 through Day 6). 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 9 Sep 2016.