BOx-II: Brain Oxygenation-II
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Interventional Arm 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. |
Other: Intervention for cerebral hypoxia
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.
|
Outcome Measures
Primary Outcome Measures
- Frequency of interventions used to address cerebral hypoxia [From birth until 72 hours of life]
Frequency of specific interventions chosen to address cerebral hypoxia
Secondary Outcome Measures
- Rates of cerebral hypoxia and systemic hypoxia [From birth until 72 hours of life]
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
- Rates of death or severe brain injury [36-42 weeks corrected gestational age]
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.
Other Outcome Measures
- Rates of other neonatal morbidities [Birth until hospital discharge, an average of 3 months]
Rates of other neonatal morbidities including bronchopulmonary dysplasia, severe retinopathy of prematurity, and/or mortality before neonatal intensive care unit discharge
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Infants born with postmenstrual age less than 28 weeks
-
Signed informed consent
Exclusion Criteria:
-
Missing written parental informed consent
-
Decision not to conduct full intensive care support
-
No possibility to place cerebral NIRS oximeter within six hours after birth
-
Skin integrity insufficient to allow for sensor placement as deemed by a clinician
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Loma Linda University | Loma Linda | California | United States | 92350 |
| 2 | Stanford University | Palo Alto | California | United States | 94304 |
| 3 | Washington University in Saint Louis | Saint Louis | Missouri | United States | 63110 |
| 4 | University of Texas- Southwestern Medical Center | Dallas | Texas | United States | 75390 |
| 5 | University of Virginia | Charlottesville | Virginia | United States | 22903 |
Sponsors and Collaborators
- Valerie Chock, M.D., M.S. Epi
- Washington University School of Medicine
- Cerebral Palsy Alliance
Investigators
- Principal Investigator: Valerie Chock, MD, Stanford University
- Principal Investigator: Zachary Vesoulis, MD, Washington University in Saint Louis
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 56759b