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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
| Cerebral Palsy Alliance | OTHER |
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The Brain Oxygenation-II study (BOx-II) is a phase-II, multicenter, single-arm clinical trial evaluating interventions based on near-infrared spectroscopy (NIRS) monitoring of cerebral oxygen saturation in extremely premature infants. Enrolled infants will follow a treatment guideline to maintain cerebral oxygen saturation in a target range within the first 72 hours of life. The primary outcomes will include interventions used to maintain cerebral saturation in target range, rates of cerebral hypoxia and systemic hypoxia, and a composite of death or severe brain injury detected on term-equivalent magnetic resonance imaging.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Arm | Experimental | All infants will undergo non-invasive NIRS monitoring of cerebral oxygen saturation and will have algorithm-driven clinical interventions to maintain cerebral saturation within target range during the first 72 hours of life. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention for cerebral hypoxia | Other | For cerebral oxygen saturation measures below target range (cerebral hypoxia), a treatment algorithm with the following potential clinical interventions will be applied: fluid resuscitation, initiation of vasopressor/inotrope medication, change in mechanical ventilation or respiratory support, adjustment of fractional inspired oxygen, transfusion of red blood cells, acquisition of echocardiogram or cranial ultrasound. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of interventions used to address cerebral hypoxia | Frequency of specific interventions chosen to address cerebral hypoxia | From birth until 72 hours of life |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of cerebral hypoxia and systemic hypoxia | Rates of cerebral hypoxia as detected by near-infrared spectroscopy (NIRS) monitoring of cerebral oxygen saturation and systemic hypoxia as detected by conventional pulse oximetry monitoring of systemic oxygen saturation | From birth until 72 hours of life |
| Rates of death or severe brain injury |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of other neonatal morbidities | Rates of other neonatal morbidities including bronchopulmonary dysplasia, severe retinopathy of prematurity, and/or mortality before neonatal intensive care unit discharge | Birth until hospital discharge, an average of 3 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Valerie Chock, MD | Stanford University | Principal Investigator |
| Zachary Vesoulis, MD | Washington University in Saint Louis | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University | Loma Linda | California | 92350 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35995129 | Derived | Vesoulis Z, Hopper A, Fairchild K, Zanelli S, Chalak L, Noroozi M, Liu J, Chock V. A phase-II clinical trial of targeted cerebral near infrared spectroscopy using standardized treatment guidelines to improve brain oxygenation in preterm infants (BOx-II): A study protocol. Contemp Clin Trials. 2022 Sep;120:106886. doi: 10.1016/j.cct.2022.106886. Epub 2022 Aug 19. |
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| ID | Term |
|---|---|
| D002534 | Hypoxia, Brain |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D000860 | Hypoxia |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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Single arm interventional study to maintain cerebral oxygen saturation in targeted range
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Rates of death or severe brain injury (including intraventricular hemorrhage, white matter injury, cystic periventricular leukomalacia, cerebellar hemorrhage, post-hemorrhagic ventricular dilation, or cerebral atrophy) detected on term-equivalent magnetic resonance imaging performed between 36 and 42 weeks corrected gestational age. |
| 36-42 weeks corrected gestational age |
| Palo Alto |
| California |
| 94304 |
| United States |
| Washington University in Saint Louis | St Louis | Missouri | 63110 | United States |
| University of Texas- Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| D012818 |
| Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |