NCT05171881

Brain Oxygenation-II

Brain Oxygenation in Extremely Preterm Infants-II

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Valerie Chock, M.D., M.S. Epi · Academic / Other
• Sex: All
• Age: 6 Hours
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Hypoxia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-07
• Primary completion: 2024-12-01
• Completion: 2025-04-01
• First posted: 2021-12-29
• Last updated: 2024-04-18

Locations

5 sites across 1 country: United States