A Phase 2 interventional study of Intervention for cerebral hypoxia in Cerebral Hypoxia, sponsored by Valerie Chock, M.D., M.S. Epi. Active, not recruiting at 5 sites in United States. Open to participants aged Up to 6 Hours. Per ClinicalTrials.gov, last updated 2024-04-18.
Sponsored by Valerie Chock, M.D., M.S. Epi · Phase 2, Interventional, and Diagnostic
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.
81 studies on the registry are indexed under Hypoxia, Brain; 19 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 55 interventional studies indexed under Hypoxia, Brain.
Browse Hypoxia, Brain studies →This is the only study on the registry with Valerie Chock, M.D., M.S. Epi as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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
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
Time frame: Birth until hospital discharge, an average of 3 months
This study is active, not recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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