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Enrollenment has been suspended due to poor enrollment
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| Name | Class |
|---|---|
| Mallinckrodt | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inhaled nitric oxide | Drug |
|
| |
| Placebo Comparator - nitrogen gas |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Had the Need for Exogenous Surfactant | 7 days | |
| Total Length of Hospital Stay | participants who were followed for the duration of hospital stay | From hospital admission through discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer W Lee, MD, MS | Tufts Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Inhaled Nitric Oxide (iNO) | Number of participants who have started on iNO at 20 parts per million (ppm) for the first three days of life. The dose was 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. inhaled nitric oxide |
| FG001 | Nitrogen Gas | Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was 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. Placebo Comparator - nitrogen gas |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Inhaled Nitric Oxide | iNO 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. inhaled nitric oxide |
| BG001 | Nitrogen Gas |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Who Were Alive Without the Need for Intubation or Mechanical Ventilation Within the First Week of Life | Posted | Count of Participants | Participants | 7 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inhaled Nitric Oxide | Number of participants who have started on iNO at 20ppm for the first three days of life. The dose was 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. inhaled nitric oxide |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Murmur | Cardiac disorders | Infant developed a murmur consistent with peripheral pulmonic stenosis and anemia. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Christiane Dammann | Tufts Medical Center | 617-636-8738 | cdammann@tuftsmedicalcenter.org |
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| ID | Term |
|---|---|
| D001997 | Bronchopulmonary Dysplasia |
| ID | Term |
|---|---|
| D055397 | Ventilator-Induced Lung Injury |
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007288 | Inosine |
| D045462 | Endothelium-Dependent Relaxing Factors |
| ID | Term |
|---|---|
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Drug |
|
| Total Duration of Supplemental Oxygen | Participants were followed for the duration of hospital stay for use of supplemental oxygen | 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. | 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) | 12 months corrected gestational age |
| Total Duration of Respiratory Support | participants were followed for the duration of hospital stay for respiratory support | From hospital admission through discharge |
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. Placebo Comparator - nitrogen gas |
| BG002 | Total | Total of all reporting groups |
| days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
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| Secondary | Number of Participants Who Had the Need for Exogenous Surfactant | Posted | Count of Participants | Participants | 7 days |
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|
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| Secondary | Total Length of Hospital Stay | participants who were followed for the duration of hospital stay | Posted | Mean | Standard Deviation | days | From hospital admission through discharge |
|
|
|
| Secondary | Total Duration of Supplemental Oxygen | Participants were followed for the duration of hospital stay for use of supplemental oxygen | Posted | Mean | Standard Deviation | days | From Hospital Admission through discharge |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | At 36 weeks postmenstrual age or 1-2month of age |
|
|
|
| Secondary | 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) | Analysis not performed at one year corrected age, since study closed. | Posted | Count of Participants | Participants | 12 months corrected gestational age |
|
|
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| Secondary | Total Duration of Respiratory Support | participants were followed for the duration of hospital stay for respiratory support | Posted | Mean | Standard Deviation | days | From hospital admission through discharge |
|
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|
| 0 |
| 2 |
| 1 |
| 2 |
| EG001 | Nitrogen Gas | Number of participants who have started on placebo gas that was adjusted the same as study gas: to start at 20ppm for the first three days of life. The dose was 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. Placebo Comparator - nitrogen gas | 0 | 1 | 0 | 1 |
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| D007235 |
| Infant, Premature, Diseases |
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D014665 | Vasodilator Agents |
| D002317 | Cardiovascular Agents |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |