Brain Oxygenation-II

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-07

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Cerebral Hypoxia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm interventional study to maintain cerebral oxygen saturation in targeted range

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Interventional Arm

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.

Group Type EXPERIMENTAL

Intervention for cerebral hypoxia

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Maximum Eligible Age

6 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No