Brain Oxygenation-II (BOx-II)

Brain Oxygenation in Extremely Preterm Infants-II

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 Overview

• Status: Active, not recruiting
• Conditions: Cerebral Hypoxia
• Intervention / Treatment: Other: Intervention for cerebral hypoxia

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92350
      • Loma Linda University
    • Palo Alto, California, United States, 94304
      • Stanford University
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University in Saint Louis
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas- Southwestern Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 6 hours (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Interventional Arm; 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of interventions used to address cerebral hypoxia	Frequency of specific interventions chosen to address cerebral hypoxia	From birth until 72 hours of life

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	36-42 weeks corrected gestational age

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rates of other neonatal morbidities	Rates of other neonatal morbidities including bronchopulmonary dysplasia, severe retinopathy of prematurity, and/or mortality before neonatal intensive care unit discharge	Birth until hospital discharge, an average of 3 months

Collaborators and Investigators

• Sponsor: Valerie Chock, M.D., M.S. Epi
• Collaborators: Washington University School of Medicine; Cerebral Palsy Alliance
• Investigators: Principal Investigator: Zachary Vesoulis, MD, Washington University in Saint Louis; Principal Investigator: Valerie Chock, MD, Stanford University

Publications and helpful links

General Publications

• Vesoulis Z, Hopper A, Fairchild K, Zanelli S, Chalak L, Noroozi M, Liu J, Chock V. A phase-II clinical trial of targeted cerebral near infrared spectroscopy using standardized treatment guidelines to improve brain oxygenation in preterm infants (BOx-II): A study protocol. Contemp Clin Trials. 2022 Sep;120:106886. doi: 10.1016/j.cct.2022.106886. Epub 2022 Aug 19.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: December 28, 2021
• First Posted (Actual): December 29, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Signs and Symptoms, Respiratory; Hypoxia; Hypoxia, Brain
• Other Study ID Numbers: 56759b

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No