Brain Oxygenation-II

Study Overview
=================
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.

Official Title
-----------------
Brain Oxygenation in Extremely Preterm Infants-II

Conditions
-----------------
Cerebral Hypoxia

Intervention / Treatment
-----------------
* Other: Intervention for cerebral hypoxia


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Maximum Age: 6 Hours

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm interventional study to maintain cerebral oxygen saturation in targeted range
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interventional Arm<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 36-42 weeks corrected gestational age |