Brain Oxygenation-II

NCT05171881 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 56759b
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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.

Conditions

Cerebral Hypoxia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Rates of cerebral hypoxia and systemic hypoxia

  From birth until 72 hours of life

• Rates of death or severe brain injury

  36-42 weeks corrected gestational age

Other Outcomes (1)

• Rates of other neonatal morbidities

  Birth until hospital discharge, an average of 3 months

Study Arms (1)

Interventional Arm

EXPERIMENTAL

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

Interventions

Intervention for cerebral hypoxia OTHER

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.

Interventional Arm

Eligibility Criteria

• Age: Up to 6 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Valerie Chock, M.D., M.S. Epi: lead
• Washington University School of Medicine: collaborator
• Cerebral Palsy Alliance: collaborator

Study Sites (5)

Loma Linda University

Loma Linda, California, 92350, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Washington University in Saint Louis

St Louis, Missouri, 63110, United States

Location

University of Texas- Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• 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.

  PMID: 35995129 DERIVED

MeSH Terms

Conditions

Hypoxia, Brain

Interventions

Methods

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Valerie Chock, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

• Zachary Vesoulis, MD

  Washington University in Saint Louis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: Single arm interventional study to maintain cerebral oxygen saturation in targeted range

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: December 29, 2021
• Study Start: April 7, 2022
• Primary Completion: December 1, 2024
• Study Completion: April 1, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

US (5)