Bronchopulmonary DysplasiaPhase 3NCT00931632
Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants
A Phase 3 study testing Inhaled Nitric Oxide in people with Bronchopulmonary Dysplasia, run by Mallinckrodt at 33 sites in 2 countries.
Trial summary
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO. Read more about this study
- Who is it for?
- Ages 5 to 14 days
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Inhaled Nitric Oxide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 451 participants
- Where
- 33 sitesin 2 countries
- Study dates
- Nov 2009to May 2014
- Phase
- Phase 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 5 to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants who are:
- 500 to 1250 grams at birth
- < 30 weeks gestational age
- 5 to 14 days of age (inclusive) at the time of entry
- Requiring mechanical ventilation or for those infants ≤ 800 grams, positive pressure support (including CPAP) for respiratory insufficiency on days 5 to 14 days of age (inclusive)
Who cannot join
- Preterm infants with life-threatening anomalies (cranial, cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject who will not receive complete intensive care
- Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)
- Subjects who are dependent on right to left shunting to maintain the systemic circulation
- Preterm infants who received prior iNO therapy
- Use of another investigational agent
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States31 sites
Medical College of Georgia
Augusta, Georgia, 30912
Cook Children's Medical Center
Fort Worth, Texas, 76104
Greenville Memorial Hospital
Greenville, South Carolina, 29605
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Riley Hospital for Children
Indianapolis, Indiana, 46202
Saint Barnabas Medical Center
Livingston, New Jersey, 07039
Loma Linda University School of Medicine
Loma Linda, California, 92354
University of Louisville School of Medicine
Louisville, Kentucky, 40202
Wheaton Franciscan Healthcare
Milwaukee, Wisconsin, 53210
Winthrop University Hospital
Mineola, New York, 11501
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Children's Hospital of Orange County
Orange, California, 92868
Winnie Palmer Hospital for Women and Babies
Orlando, Florida, 32806
Stanford University School of Medicine
Palo Alto, California, 94304
Advocate Lutheran General Children's Hospital
Park Ridge, Illinois, 60068
Phoenix Children's Hospital
Phoenix, Arizona, 85006
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
WakeMed Faculty Physicians, Neonatology
Raleigh, North Carolina, 27610
Virginia Commonwealth University
Richmond, Virginia, 23298
Primary Children's Medical Center
Salt Lake City, Utah, 84113
Rady Children's Hospital of San Diego
San Diego, California, 92123
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
Sanford Children's Hospital
Sioux Falls, South Dakota, 57117
University of So Florida College of Medicine
Tampa, Florida, 33606
Montefiore Medical Center
The Bronx, New York, 10461
Mercy Children's Hospital
Toledo, Ohio, 43608
Saint Francis Children's Hospital
Tulsa, Oklahoma, 74136
Maria Fareri Children's Hospital at Westchester Medical Center
Valhalla, New York, 10595
Children's Corporate Center, Division of Neonatology
Wauwatosa, Wisconsin, 53226
Canada2 sites
University of Calgary
Calgary, Alberta, T2N 4N1
Centre Hospitalier Universitaire de Quebec
Québec, G1V 4G2
About this study
Official title: Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants Requiring Mechanical Ventilation or Positive Pressure Support on Days 5-14 After Birth
This phase 3, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.
Read the detailed description
Multi-center, double blind, placebo-controlled, randomized clinical trial. Infants who meet all enrollment criteria at any point during days 5 to 14 after birth will be randomized to inhaled NO starting at 20 ppm, or matching placebo, by means of a blinded INOvent® delivery device. All infants will receive 24 days of therapy, following a dose reduction schedule. Infants who are extubated before 24 days will continue therapy via nasal continuous positive airway pressure (CPAP) or nasal cannula to complete 24 days' of therapy. The primary outcome measure will be survival without BPD at 36 weeks gestational age using a physiologic assessment of BPD.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Inhaled Nitric Oxide, Placebo
- Keywords
- Bronchopulmonary Dysplasia, BPD
- Medical subject headings
- Bronchopulmonary Dysplasia
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 into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy.
PlaceboDrug
Also called Nitrogen gas
Nitrogen gas will be administered in the same manner as the experimental drug.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Nitric Oxide | Experimental | Inhaled Nitric Oxide Receives: Drug: Inhaled Nitric Oxide |
| Placebo | Placebo comparator | Nitrogen Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival Without BPD at 36 Weeks
Measured: Baseline, 36 weeks PMA
Secondary outcomes (7)
Days of Airway Pressure Support - Intent-to-treat Population
Airway pressure support includes conventional mechanical ventilation, conventional, high frequency oscillatory ventilation, jet, continuous positive airway pressure, and other.
Measured: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Length of Birth Hospitalization
Measured: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia
Measured: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason
Measured: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Systemic Use of Postnatal Corticosteroids for Any Medical Reason
Measured: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Number of Days of Oxygen Use
Measured: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Severity of Bronchopulmonary Dysplasia
Severity of bronchopulmonary dysplasia defined by the fraction of inspired O2 concentration (FiO2) requirement.
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2009 (estimated)
- Study startNov 2009
- Primary completionMay 2013
- Study completionMay 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bronchopulmonary DysplasiaStudies 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
- 451 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
- NCT00931632
- Sponsor's protocol ID
- IK-3001-BPD-301
- Status last verified
- Oct 2017
- First submitted
- 1 Jul 2009
- Last updated
- 4 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hasan SU, Potenziano J, Konduri GG, Perez JA, Van Meurs KP, Walker MW, Yoder BA; Newborns Treated With Nitric Oxide (NEWNO) Trial Group. Effect of Inhaled Nitric Oxide on Survival Without Bronchopulmonary Dysplasia in Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2017 Nov 1;171(11):1081-1089. doi: 10.1001/jamapediatrics.2017.2618.
PubMed 28973344
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Nitric Oxide (INO) for the Prevention of Bronchopulmonary Dysplasia (BPD) in Preterm Infants Requiring Mechanical Ventilation or Positive Pressure Support on Days 5-14 After Birth
- ClinicalTrials.gov ID
- NCT00931632
- Acronym / sponsor ID
- IK-3001-BPD-301
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Bronchopulmonary Dysplasia, BPD
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- Nov 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 2 Jul 2009 (estimated)
- Results
- Posted 11 Aug 2015
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, multi-center, double blind, placebo-controlled, randomized clinical trial will attempt to demonstrate if preterm infants who require mechanical ventilation and/or positive pressure support at any point during days 5 to 14 after birth may benefit from treatment with iNO.
Detailed description
Multi-center, double blind, placebo-controlled, randomized clinical trial. Infants who meet all enrollment criteria at any point during days 5 to 14 after birth will be randomized to inhaled NO starting at 20 ppm, or matching placebo, by means of a blinded INOvent® delivery device. All infants will receive 24 days of therapy, following a dose reduction schedule. Infants who are extubated before 24 days will continue therapy via nasal continuous positive airway pressure (CPAP) or nasal cannula to complete 24 days' of therapy. The primary outcome measure will be survival without BPD at 36 weeks gestational age using a physiologic assessment of BPD.
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 |
| Placebo | Placebo comparator | Drug: PlaceboNitrogen Placebo |
Who may qualify
- Ages
- 5 to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Preterm infants who are:
Key exclusion criteria (5 listed)
- Preterm infants with life-threatening anomalies (cranial, cardiac, thoracic, chromosomal) or congenital diaphragmatic hernia with lung hypoplasia, or any subject who will not receive complete intensive care
- Preterm infants with bilateral Grade 4 intraventricular hemorrhage (IVH)
- Subjects who are dependent on right to left shunting to maintain the systemic circulation
- Preterm infants who received prior iNO therapy
- Use of another investigational agent
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 into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy. | Drug | Inhaled Nitric Oxide |
| PlaceboAlso: Nitrogen gasNitrogen gas will be administered in the same manner as the experimental drug. | Drug | Placebo |
Primary outcome
Survival Without BPD at 36 Weeks
Time frame: Baseline, 36 weeks PMA
7 secondary outcomes
Days of Airway Pressure Support - Intent-to-treat Population
Time frame: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Length of Birth Hospitalization
Time frame: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Bronchopulmonary Dysplasia
Time frame: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Number and Percentage of Participants With Use of Postnatal Corticosteroids for Any Medical Reason
Time frame: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Systemic Use of Postnatal Corticosteroids for Any Medical Reason
Time frame: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Number of Days of Oxygen Use
Time frame: Through hospital discharge, an average of 105 days for placebo and 108 days for INO
Severity of Bronchopulmonary Dysplasia
Time frame: 36 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 28973344Hasan SU, Potenziano J, Konduri GG, Perez JA, Van Meurs KP, Walker MW, Yoder BA; Newborns Treated With Nitric Oxide (NEWNO) Trial Group. Effect of Inhaled Nitric Oxide on Survival Without Bronchopulmonary Dysplasia in Preterm Infants: A Randomized Clinical Trial. JAMA Pediatr. 2017 Nov 1;171(11):1081-1089. doi: 10.1001/jamapediatrics.2017.2618.
Related trials for Bronchopulmonary Dysplasia
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Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
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Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
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Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Inhaled Nitric Oxide in people with Bronchopulmonary Dysplasia, run by Mallinckrodt at 33 sites in 2 countries.
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 5 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 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Canada. 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?
Yes. Results are posted in the registry (first posted 11 Aug 2015). 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?
Survival Without BPD at 36 Weeks (time frame: Baseline, 36 weeks PMA). 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 NCT00931632, 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 4 Dec 2017.