Cerebral Hypoxia
Conditions
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.
Interventions
OTHERIntervention 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.
Sponsors
Washington University School of Medicine
Cerebral Palsy Alliance
Valerie Chock, M.D., M.S. Epi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single arm interventional study to maintain cerebral oxygen saturation in targeted range
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Hours
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of interventions used to address cerebral hypoxia | From birth until 72 hours of life | Frequency of specific interventions chosen to address cerebral hypoxia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rates of cerebral hypoxia and systemic hypoxia | From birth until 72 hours of life | 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 | 36-42 weeks corrected gestational age | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rates of other neonatal morbidities | Birth until hospital discharge, an average of 3 months | Rates of other neonatal morbidities including bronchopulmonary dysplasia, severe retinopathy of prematurity, and/or mortality before neonatal intensive care unit discharge |
Countries
United States
Outcome results
None listed