Brain Oxygenation-II (BOx-II)

Valerie Chock, M.D., M.S. Epi

Status and phase: Active, not recruiting; Phase 2

Conditions: Cerebral Hypoxia

Treatments: Other: Intervention for cerebral hypoxia

Study type: Interventional

Funder types: Other

Identifiers

NCT05171881

56759b

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 6 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Interventional Arm

Experimental group

Description:

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.

Treatment:

Other: Intervention for cerebral hypoxia