Cerebral HypoxiaPhase 2BOx-IINCT05171881
Brain Oxygenation-II
A Phase 2 study testing Intervention for cerebral hypoxia in people with Cerebral Hypoxia, run by Valerie Chock, M.D., M.S. Epi at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 hours
- Conditions the study is for
- Cerebral Hypoxia
- What is being tested?
- Intervention for cerebral hypoxia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesUnited States
- Study dates
- 7 Apr 2022to Apr 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants born with postmenstrual age less than 28 weeks
- Signed informed consent
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Virginia
Charlottesville, Virginia, 22903
University of Texas- Southwestern Medical Center
Dallas, Texas, 75390
Loma Linda University
Loma Linda, California, 92350
Stanford University
Palo Alto, California, 94304
Washington University in Saint Louis
St Louis, Missouri, 63110
About this study
Official title: 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.
- Conditions
- Cerebral Hypoxia
- Being tested
- Intervention for cerebral hypoxia
- Medical subject headings
- Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intervention for cerebral hypoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of interventions used to address cerebral hypoxia
Frequency of specific interventions chosen to address cerebral hypoxia
Measured: From birth until 72 hours of life
Secondary outcomes (2)
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
Measured: 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.
Measured: 36-42 weeks corrected gestational age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2021
- Study start7 Apr 2022
- Primary completionDec 2024 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm interventional study to maintain cerebral oxygen saturation in targeted range
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valerie Chock, M.D., M.S. Epi
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine, Cerebral Palsy Alliance
- Responsible party
- Sponsor-investigator, Valerie Chock, M.D., M.S. Epi, Stanford University
- Investigators
- Valerie Chock, MD, Principal investigator, Stanford UniversityZachary Vesoulis, MD, Principal investigator, Washington University in Saint Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05171881
- Sponsor's protocol ID
- 56759b
- Acronym
- BOx-II
- Status last verified
- Apr 2024
- First submitted
- 26 Nov 2021
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 35995129
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Oxygenation in Extremely Preterm Infants-II
- ClinicalTrials.gov ID
- NCT05171881
- Acronym / sponsor ID
- BOx-II / 56759b
- Conditions
- Cerebral Hypoxia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Valerie Chock, M.D., M.S. EpiUniversity, hospital or other
- Collaborators
- Washington University School of Medicine, Cerebral Palsy Alliance
- Study start
- 7 Apr 2022 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 29 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm interventional study to maintain cerebral oxygen saturation in targeted range
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Other: Intervention for cerebral hypoxiaAll 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. |
Who may qualify
- Ages
- Up to 6 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Infants born with postmenstrual age less than 28 weeks
- Signed informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention for cerebral hypoxiaFor 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. | Other | Interventional Arm |
Primary outcome
Frequency of interventions used to address cerebral hypoxia
Time frame: From birth until 72 hours of life
Frequency of specific interventions chosen to address cerebral hypoxia
2 secondary outcomes
Rates of cerebral hypoxia and systemic hypoxia
Time frame: From birth until 72 hours of life
Rates of death or severe brain injury
Time frame: 36-42 weeks corrected gestational age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Derived from this study: PubMed 35995129Vesoulis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Chock, MD principal investigator
Stanford University
Zachary Vesoulis, MD principal investigator
Washington University in Saint Louis
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Intervention for cerebral hypoxia in people with Cerebral Hypoxia, run by Valerie Chock, M.D., M.S. Epi at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of interventions used to address cerebral hypoxia (time frame: From birth until 72 hours of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05171881, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024; AzTrials last refreshed its copy on 28 Oct 2026.