Bronchopulmonary DysplasiaPhase 2/3NCT01748045
Study of Inhaled Nitric Oxide (iNO) and Respiratory Outcomes in Late Preterm Infants
A Phase 2/3 study testing inhaled nitric oxide in people with Bronchopulmonary Dysplasia, run by Tufts Medical Center at 1 site in United States.
Trial summary
The aim of this study is to determine if inhaled nitric oxide will improve short and long term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36 weeks and who require breathing support with high flow nasal cannula, nasal continuous positive airway pressure, or nasal intermittent… Read more about this study
- Who is it for?
- Ages 30 to 36 weeks
- 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
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jul 2014
- Phase
- Phase 2/3
- 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 30 to 36 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- <48 hours of age,
- 30 - 36 weeks gestational age at birth based on best estimate using obstetrical sonography (first or second trimester), solid dating criteria, or Ballard examination,
- Birth weight of ≥ 1,000 g,
- 5 minute Apgar score ≥5,
- Requiring nasal cannula O2 > 1 liter per minute (LPM), continuous positive pressure (CPAP), or non invasive positive pressure ventilation (NIPPV) for treatment of respiratory failure,
- Requiring a fraction of inspired oxygen (FIO2) of at least 0.25 to maintain arterial oxygen saturation (SaO2) 88-94%,
- Parent or guardian has signed informed consent and agrees to all study- related procedures, including those required after hospital discharge.
Who cannot join
- Major congenital anomaly
- Intubation and surfactant in the delivery room or prior to enrollment in the Neonatal Intensive Care Unit (NICU). Excludes intubation for suctioning.
- Known congenital infection (bacterial, viral),
- Perinatal asphyxia (5 minute Apgar <5, umbilical artery pH < 7.0 or evidence of neonatal encephalopathy),
- Mother and/or infant is enrolled in another clinical trial (excluding observational) or has received an investigational drug,
- Has undergone or is anticipated to require a major surgical procedure within the first 48 h of life,
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- Any condition which could preclude receiving study drug or performing any study-related procedures,
- Use of postnatal corticosteroids,
- Parent or guardian is unable or unwilling to complete study procedures after hospital discharge.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Inhaled Nitric Oxide to Improve Respiratory Outcomes in Late Preterm Infants
The aim of this study is to determine if inhaled nitric oxide will improve short and long term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36 weeks and who require breathing support with high flow nasal cannula, nasal continuous positive airway pressure, or nasal intermittent positive pressure will be randomized to receive either inhaled nitric oxide or placebo. The dose will then be decreased per protocol until all respiratory support has been discontinued. Infants will be followed to evaluate safety and efficacy of non-invasive iNO delivery, up to 12 months corrected gestational age.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- inhaled nitric oxide, Placebo Comparator - nitrogen gas
- Keywords
- Inhaled Nitric Oxide, Bronchopulmonary Dysplasia, Late Prematurity, Chronic Respiratory Morbidity
- 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 iNO, INOmax
Placebo Comparator - nitrogen gasDrug
| Study group | Role | What they receive |
|---|---|---|
| inhaled Nitric Oxide | Experimental | iNO to start at 20 parts per million (ppm) for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued. Receives: Drug: inhaled nitric oxide |
| Nitrogen Gas | Placebo comparator | Placebo gas will be adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued. Receives: Drug: Placebo Comparator - nitrogen gas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life
Measured: 7 days
Secondary outcomes (6)
Number of Participants Who Had the Need for Exogenous Surfactant
Measured: 7 days
Total Length of Hospital Stay
participants who were followed for the duration of hospital stay
Measured: From hospital admission through discharge
Total Duration of Supplemental Oxygen
Participants were followed for the duration of hospital stay for use of supplemental oxygen
Measured: From Hospital Admission through discharge
Diagnosis of Bronchopulmonary Dysplasia (BPD)
Diagnosis of BPD by oxygen challenge test at 36 weeks post menstrual age (PMA) for infants born between 30 and 32 weeks gestational age (GA). For those born 32 1/7 - 36 weeks, an oxygen challenge test was performed at 1-2 months of age.
Measured: At 36 weeks postmenstrual age or 1-2month of age
Evidence of Chronic Respiratory Morbidity at 12 Months Corrected Gestational Age (CGA)
defined by a validated system of parental diaries and pulmonary questionnaires, as well as review of medical records (medical visits, respiratory medication use, emergency room visits, and hospital re-admissions)
Measured: 12 months corrected gestational age
Total Duration of Respiratory Support
participants were followed for the duration of hospital stay for respiratory support
Measured: From hospital admission through discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Enrollenment has been suspended due to poor enrollment
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.
- 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Mallinckrodt
- Responsible party
- Sponsor
- Investigators
- Jennifer W Lee, MD, MS, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748045
- Sponsor's protocol ID
- 10487
- Status last verified
- Jun 2017
- First submitted
- 20 Nov 2012
- Last updated
- 19 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Inhaled Nitric Oxide to Improve Respiratory Outcomes in Late Preterm Infants
- ClinicalTrials.gov ID
- NCT01748045
- Acronym / sponsor ID
- 10487
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Inhaled Nitric Oxide, Bronchopulmonary Dysplasia, Late Prematurity, Chronic Respiratory Morbidity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollenment has been suspended due to poor enrollment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Mallinckrodt
- Study start
- Mar 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Posted 19 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to determine if inhaled nitric oxide will improve short and long term respiratory outcomes in preterm infants. Infants born at a gestational age of 30-36 weeks and who require breathing support with high flow nasal cannula, nasal continuous positive airway pressure, or nasal intermittent positive pressure will be randomized to receive either inhaled nitric oxide or placebo. The dose will then be decreased per protocol until all respiratory support has been discontinued. Infants will be followed to evaluate safety and efficacy of non-invasive iNO delivery, up to 12 months corrected gestational age.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inhaled Nitric Oxide | Experimental | Drug: inhaled nitric oxideiNO to start at 20 parts per million (ppm) for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued. |
| Nitrogen Gas | Placebo comparator | Drug: Placebo Comparator - nitrogen gasPlacebo gas will be adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose will then be decreased to 10 ppm for three days, 5 ppm for 3 days and then 2 ppm until all high flow respiratory support has been discontinued. |
Who may qualify
- Ages
- 30 to 36 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- <48 hours of age,
- 30 - 36 weeks gestational age at birth based on best estimate using obstetrical sonography (first or second trimester), solid dating criteria, or Ballard examination,
- Birth weight of ≥ 1,000 g,
- 5 minute Apgar score ≥5,
- Requiring nasal cannula O2 > 1 liter per minute (LPM), continuous positive pressure (CPAP), or non invasive positive pressure ventilation (NIPPV) for treatment of respiratory failure,
Key exclusion criteria (9 listed)
- Major congenital anomaly
- Intubation and surfactant in the delivery room or prior to enrollment in the Neonatal Intensive Care Unit (NICU). Excludes intubation for suctioning.
- Known congenital infection (bacterial, viral),
- Perinatal asphyxia (5 minute Apgar <5, umbilical artery pH < 7.0 or evidence of neonatal encephalopathy),
- Mother and/or infant is enrolled in another clinical trial (excluding observational) or has received an investigational drug,
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, INOmax | Drug | inhaled Nitric Oxide |
| Placebo Comparator - nitrogen gas | Drug | Nitrogen Gas |
Primary outcome
Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life
Time frame: 7 days
6 secondary outcomes
Number of Participants Who Had the Need for Exogenous Surfactant
Time frame: 7 days
Total Length of Hospital Stay
Time frame: From hospital admission through discharge
Total Duration of Supplemental Oxygen
Time frame: From Hospital Admission through discharge
Diagnosis of Bronchopulmonary Dysplasia (BPD)
Time frame: At 36 weeks postmenstrual age or 1-2month of age
Evidence of Chronic Respiratory Morbidity at 12 Months Corrected Gestational Age (CGA)
Time frame: 12 months corrected gestational age
Total Duration of Respiratory Support
Time frame: From hospital admission through discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Bronchopulmonary Dysplasia
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Recruiting
Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
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.
Jennifer W Lee, MD, MS principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing inhaled nitric oxide in people with Bronchopulmonary Dysplasia, run by Tufts Medical Center 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 7 inclusion and 9 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 Jul 2017. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 19 Jul 2017). 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?
Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life (time frame: 7 days). 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 19 Jul 2017.