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| ID | Type | Description | Link |
|---|---|---|---|
| R01HL173488 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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The goal of this observational study is to determine whether a marker of dead space (the end-tidal to alveolar dead space fraction [AVDSf]) is more strongly associated with mortality risk than markers of oxygenation abnormality (oxygenation index) and to determine whether dead space (AVDSf) is an important marker of heterogeneity in the inhaled nitric oxide (iNO) treatment effect for children with acute respiratory distress syndrome (ARDS).
The study aims are:
This is a prospective, multicenter observational study of 1260 mechanically ventilated children with moderate to severe ARDS. In a subgroup of 450 children with severe ARDS, longitudinal blood samples will be obtained to measure plasma protein markers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Children with moderate to severe ARDS |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that experience all-cause mortality within 28 days from start of invasive mechanical ventilation | 28 day all-cause mortality | From the start of invasive mechanical ventilation to 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that experience all-cause mortality within 90 days from start of invasive mechanical ventilation | 90 day all-cause mortality | From the start of invasive mechanical ventilation to 90 days |
| 28-Day Ventilator-Free Days |
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Inclusion Criteria:
Exclusion Criteria:
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Children with moderate to severe ARDS
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jeni Kwok | Contact | 3233617939 | dinostudy@chla.usc.edu | |
| Anoopindar Bhalla, MD | Contact | 3233617939 | abhalla@chla.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Anoopindar M Bhalla, MD | Children's Hospital Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Recruiting | Los Angeles | California | 90027 | United States |
Deidentified public use dataset will be created.
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available in 2029
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The number of days within the first 28 days of invasive mechanical ventilation for ARDS that a patient is alive and free of mechanical ventilation.
| From the start of invasive mechanical ventilation to 28 days |
| The days on invasive mechanical ventilation for survivors of ARDS | The number of days that a patient that survives is on invasive mechanical ventilation (up to 90 days) | From the start of invasive mechanical ventilation to the end of invasive mechanical ventilation (or 90 days after the start of invasive mechanical ventilation if the patient is still on invasive mechanical ventilation at 90 days) |
| The number of non-pulmonary organ failure free days within the first 14 days of invasive mechanical ventilation | Organ failure criteria will be determined with the Pediatric Organ Dysfunction Information Update Mandate. We will identify the number of days in the first 14 days of ARDS that a patient is alive and without any non-pulmonary organ failures. | From the start of invasive mechanical ventilation to 14 days |
| The number of non-pulmonary organ failures 21 days after the start of invasive mechanical ventilation | Organ failure criteria will be determined with the Pediatric Organ Dysfunction Information Update Mandate. The number of non-pulmonary organ failures on day 21 after the start of invasive mechanical ventilation will be identified. Patients that experience mortality prior to 21 days will be considered to have failure of all non-pulmonary organs. | 21 days after the start of invasive mechanical ventilation |
| The number of non-pulmonary organ failures 28 days after the start of invasive mechanical ventilation | Organ failure criteria will be determined with the Pediatric Organ Dysfunction Information Update Mandate. The number of non-pulmonary organ failures on day 28 after the start of invasive mechanical ventilation will be identified. Patients that experience mortality prior to 28 days will be considered to have failure of all non-pulmonary organs. | 28 days after the start of invasive mechanical ventilation |
| The number of non-pulmonary organs that newly meet failure criteria or have an increase in the severity of organ failure within the first 14 days of invasive mechanical ventilation | Organ failure criteria will be determined with the Pediatric Organ Dysfunction Information Update Mandate. We will identify the number of organs during the first 14 days of invasive mechanical ventilation that either have worsening of the severity of failure or new failure after the first day of invasive mechanical ventilation. | From the start of invasive mechanical ventilation to 14 days |
| The development of renal failure within the first 14 days of invasive mechanical ventilation | Renal organ failure criteria will be determined with the Pediatric Organ Dysfunction Information Update Mandate. We will identify whether during the first 14 days of invasive mechanical ventilation there is new renal failure after the first day of invasive mechanical ventilation. | From the start of invasive mechanical ventilation to 14 days |
| Non-pulmonary organ failure phenotypes that develop within the first 14 days of invasive mechanical ventilation | Organ failure criteria will be determined with the Pediatric Organ Dysfunction Information Update Mandate. We will identify 14-day non-pulmonary organ failure free phenotypes using clustering analyses. | From the start of invasive mechanical ventilation to 14 days |
| Cumulative non-pulmonary organ failure severity in the first 14 days of invasive mechanical ventilation | Organ failure scores will be quantified daily with the Pediatric Logistic Organ Dysfunction (PELOD-2) score. Children that die will be assigned the maximum value. The score will be summed over the first 14 days of invasive mechanical ventilation. | From the start of invasive mechanical ventilation to 14 days |
| The change in functional status score from baseline to hospital discharge | The baseline functional status score and the intensive care unit discharge functional status score will be compared and new morbidities will be identified. If the patient is still in the hospital after 90 days of the start of invasive mechanical ventilation the functional status score at 90 days will be used rather than the functional status score at hospital discharge. | From baseline to hospital discharge (or 90 days after the start of invasive mechanical ventilation) |
| The change in pediatric overall performance score from baseline to hospital discharge | The baseline pediatric overall performance score and the hospital discharge pediatric overall performance score will be compared and new morbidities will be identified. If the patient is still in the hospital after 90 days of the start of invasive mechanical ventilation the pediatric overall performance score at 90 days will be used rather than the pediatric overall performance score at hospital discharge. | From baseline to hospital discharge (or 90 days after the start of invasive mechanical ventilation) |
| The change in pediatric cerebral performance score from baseline to hospital discharge | The baseline pediatric cerebral performance score and the hospital discharge pediatric cerebral performance score will be compared and new morbidities will be identified. If the patient is still in the hospital after 90 days of the start of invasive mechanical ventilation the pediatric cerebral performance score at 90 days will be used rather than the pediatric cerebral performance score at hospital discharge. | From baseline to hospital discharge (or 90 days after the start of invasive mechanical ventilation) |
| All-cause mortality or the use of extracorporeal membrane oxygenation (ECMO) therapy within 28 days after the start of invasive mechanical ventilation | Patients who experience mortality or use of ECMO within 28 days of the start of invasive mechanical ventilation | From the start of invasive mechanical ventilation to 28 days |
| Children's Hospital Colorado | Not yet recruiting | Denver | Colorado | 80204 | United States |
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| Boston Children's Hospital | Not yet recruiting | Boston | Massachusetts | 02115 | United States |
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| University of Michigan / CS Mott Children's Hospital | Active, not recruiting | Ann Arbor | Michigan | 48109 | United States |
| University of Nebraska Medical Center / Children's Hospital and Medical Center | Not yet recruiting | Omaha | Nebraska | 68198 | United States |
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| Cincinnati Children's Hospital Medical Center | Not yet recruiting | Cincinnati | Ohio | 45229 | United States |
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| Children's Hospital of Philadelphia | Not yet recruiting | Philadelphia | Pennsylvania | 19104 | United States |
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| Texas Children's Hospital Baylor College of Medicine | Not yet recruiting | Houston | Texas | 77030 | United States |
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| American Family Children's Hospital / University of Wisconsin-Madison | Not yet recruiting | Madison | Wisconsin | 53792 | United States |
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| Children's Hospital of Wisconsin / Medical College of Wisconsin | Not yet recruiting | Milwaukee | Wisconsin | 53226 | United States |
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| ID | Term |
|---|---|
| D012128 | Respiratory Distress Syndrome |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
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