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Brain Oxygenation-II (BOx-II)

Primary Purpose

Cerebral Hypoxia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Intervention for cerebral hypoxia
Sponsored by
Valerie Chock, M.D., M.S. Epi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cerebral Hypoxia

Eligibility Criteria

undefined - 6 Hours (Child)All SexesDoes not accept 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

Sites / Locations

  • Loma Linda UniversityRecruiting
  • Stanford UniversityRecruiting
  • Washington University in Saint LouisRecruiting
  • University of Texas- Southwestern Medical CenterRecruiting
  • University of VirginiaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Interventional Arm

Arm 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.

Outcomes

Primary Outcome Measures

Frequency of interventions used to address cerebral hypoxia
Frequency of specific interventions chosen to address cerebral hypoxia

Secondary Outcome Measures

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
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.

Full Information

First Posted
November 26, 2021
Last Updated
March 14, 2023
Sponsor
Valerie Chock, M.D., M.S. Epi
Collaborators
Washington University School of Medicine, Cerebral Palsy Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT05171881
Brief Title
Brain Oxygenation-II
Acronym
BOx-II
Official Title
Brain Oxygenation in Extremely Preterm Infants-II
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 7, 2022 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Valerie Chock, M.D., M.S. Epi
Collaborators
Washington University School of Medicine, Cerebral Palsy Alliance

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Hypoxia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single arm interventional study to maintain cerebral oxygen saturation in targeted range
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional Arm
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
Intervention for cerebral hypoxia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Frequency of interventions used to address cerebral hypoxia
Description
Frequency of specific interventions chosen to address cerebral hypoxia
Time Frame
From birth until 72 hours of life
Secondary Outcome Measure Information:
Title
Rates of cerebral hypoxia and systemic hypoxia
Description
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
Title
Rates of death or severe brain injury
Description
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
Other Pre-specified Outcome Measures:
Title
Rates of other neonatal morbidities
Description
Rates of other neonatal morbidities including bronchopulmonary dysplasia, severe retinopathy of prematurity, and/or mortality before neonatal intensive care unit discharge
Time Frame
Birth until hospital discharge, an average of 3 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
6 Hours
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Valerie Chock, MD
Phone
650-723-5711
Email
vchock@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Chock, MD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zachary Vesoulis, MD
Organizational Affiliation
Washington University in Saint Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew Hopper, MD
Phone
909-558-7448
Email
AHopper@llu.edu
First Name & Middle Initial & Last Name & Degree
Andrew Hopper, MD
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie Chock
Phone
650-723-5711
Email
vchock@stanford.edu
Ext
Chock
Email
vchock@stanford.edu
First Name & Middle Initial & Last Name & Degree
Valerie Chock, MD
Facility Name
Washington University in Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Vesoulis, MD
Phone
314-454-6148
Email
vesoulis_z@wustl.edu
First Name & Middle Initial & Last Name & Degree
Zachary Vesoulis, MD
Facility Name
University of Texas- Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lina Chalak, MD
Phone
214-648-3753
Email
lina.chalak@utsouthwestern.edu
First Name & Middle Initial & Last Name & Degree
Lina Chalak, MD
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Fairchild, MD
Phone
434-924-5428
Email
KDF2N@hscmail.mcc.virginia.edu
First Name & Middle Initial & Last Name & Degree
Santina Zanelli, MD
Email
sz5d@virginia.edu
First Name & Middle Initial & Last Name & Degree
Karen Fairchild, MD
First Name & Middle Initial & Last Name & Degree
Santina Zanelli, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
35995129
Citation
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.
Results Reference
derived

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Brain Oxygenation-II

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