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Brain Oxygenation-II
Sponsor: Valerie Chock, M.D., M.S. Epi
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.
Official title: Brain Oxygenation in Extremely Preterm Infants-II
Key Details
Gender
All
Age Range
Any - 6 Hours
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2022-04-07
Completion Date
2025-04
Last Updated
2024-04-18
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (5)
Loma Linda University
Loma Linda, California, United States
Stanford University
Palo Alto, California, United States
Washington University in Saint Louis
St Louis, Missouri, United States
University of Texas- Southwestern Medical Center
Dallas, Texas, United States
University of Virginia
Charlottesville, Virginia, United States