Brain Oxygenation-II

Status unconfirmed · Phase 2

Conditions studied: Cerebral Hypoxia

In brief

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.

Key facts

Study ID

NCT05171881

Run by

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

People needed

100

Starts

2022-04-07

Expected to finish

2025-04-01

Last updated by the study team

2024-04-18

Who can join

Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Infants born with postmenstrual age less than 28 weeks
• Signed informed consent

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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