A Phase 2/3 interventional study of inhaled nitric oxide and Placebo Comparator - nitrogen gas in Bronchopulmonary Dysplasia, sponsored by Tufts Medical Center. Terminated at 1 site in United States. Open to participants aged 30 Weeks to 36 Weeks. Per ClinicalTrials.gov, last updated 2017-07-19.
Sponsored by Tufts Medical Center · Phase 2/3, Interventional, and Prevention
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.
339 studies on the registry are indexed under Bronchopulmonary Dysplasia; 80 are open to participants now.
This study's enrollment of 3 is below the median of 70 across 228 interventional studies indexed under Bronchopulmonary Dysplasia.
Browse Bronchopulmonary Dysplasia studies →Tufts Medical Center is the lead sponsor of 194 studies on the registry; 28 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 16 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Drug: inhaled nitric oxide
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.
Drug: Placebo Comparator - nitrogen gas
Also known as: iNO, INOmax
Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life
Time frame: 7 days
Number of Participants Who Had the Need for Exogenous Surfactant
Time frame: 7 days
Total Length of Hospital Stay
participants who were followed for the duration of hospital stay
Time frame: From hospital admission through discharge
Total Duration of Supplemental Oxygen
Participants were followed for the duration of hospital stay for use of supplemental oxygen
Time frame: 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.
Time frame: 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)
Time frame: 12 months corrected gestational age
Total Duration of Respiratory Support
participants were followed for the duration of hospital stay for respiratory support
Time frame: From hospital admission through discharge
| Milestone | Inhaled Nitric Oxide (iNO) | Nitrogen Gas |
|---|---|---|
| Started | 2 | 1 |
| Completed | 2 | 1 |
| Not completed | 0 | 0 |
| Participants | Inhaled Nitric Oxide | Nitrogen Gas |
|---|---|---|
| Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life | 2 | 1 |
| Participants | Inhaled Nitric Oxide | Nitrogen Gas |
|---|---|---|
| Number of Participants Who Had the Need for Exogenous Surfactant | 0 | 0 |
participants who were followed for the duration of hospital stay
| days | Inhaled Nitric Oxide | Nitrogen Gas |
|---|---|---|
| Total Length of Hospital Stay | 17.5 ± 2.5 | 11 ± 0 |
Participants were followed for the duration of hospital stay for use of supplemental oxygen
| days | Inhaled Nitric Oxide | Nitrogen Gas |
|---|---|---|
| Total Duration of Supplemental Oxygen | 5 ± 1 | 3 ± 0 |
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.
| Participants | Inhaled Nitric Oxide | Nitrogen Gas |
|---|---|---|
| Diagnosis of Bronchopulmonary Dysplasia (BPD) | 0 | 0 |
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)
| Participants | Inhaled Nitric Oxide | Nitrogen Gas |
|---|---|---|
| Evidence of Chronic Respiratory Morbidity at 12 Months Corrected Gestational Age (CGA) | 0 | 0 |
participants were followed for the duration of hospital stay for respiratory support
| days | Inhaled Nitric Oxide | Nitrogen Gas |
|---|---|---|
| Total Duration of Respiratory Support | 5.5 ± 1.5 | 4 ± 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Inhaled Nitric Oxide | — | 0/2 (0%) | 1/2 (50%) |
| Nitrogen Gas | — | 0/1 (0%) | 0/1 (0%) |
| Event | Inhaled Nitric Oxide | Nitrogen Gas |
|---|---|---|
| MurmurCardiac disorders | 1/2 | 0/1 |
| Age, Continuous(days) | Inhaled Nitric Oxide | Nitrogen Gas | Total |
|---|---|---|---|
| Mean | 1 ± 0 | 1 ± 0 | 1 ± 0 |
| Sex: Female, Male(Participants) | Inhaled Nitric Oxide | Nitrogen Gas | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 2 | 1 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Inhaled Nitric Oxide | Nitrogen Gas | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 0 | 1 | 1 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Race (NIH/OMB)(Participants) | Inhaled Nitric Oxide | Nitrogen Gas | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 2 |
This study is terminated, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Tufts Medical Center