Brain Oxygenation-II

Valerie Chock, M.D., M.S. Epi100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

100

Conditions

Cerebral Hypoxia

Interventions

Intervention for cerebral hypoxiaOTHER

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.

Eligibility

Sex: ALLMax age: 6 Hours

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Frequency of interventions used to address cerebral hypoxia

Frequency of specific interventions chosen to address cerebral hypoxia

Time frame: From birth until 72 hours of life

Secondary Outcomes

Rates of cerebral hypoxia and systemic hypoxia

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

Time frame: From birth until 72 hours of life

Rates of death or severe brain injury

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.

Time frame: 36-42 weeks corrected gestational age

Data from ClinicalTrials.gov

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