Brain Oxygenation-II

Phase 2

Active, not recruiting

• Conditions: Cerebral Hypoxia
• Interventions: Other: Intervention for cerebral hypoxia

• Registration Number: NCT05171881
• Lead Sponsor: Valerie Chock, M.D., M.S. Epi

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-11-26
• Study First Submitted QC: 2021-12-28
• Study First Posted: 2021-12-29
• Study Start: 2022-04-07
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2024-12
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Interventional Arm	Intervention for cerebral hypoxia	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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

Trial Locations

Locations (5)

Washington University in Saint Louis; 🇺🇸 Saint Louis, Missouri, United States

University of Texas- Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

Loma Linda University; 🇺🇸 Loma Linda, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States