What is the mechanism of action of this treatment?

The most common treatments for cerebral hypoxia include the use of Near-Infrared Spectroscopy (NIRS) monitoring, supplemental oxygen, and mechanical ventilation. NIRS monitoring helps in real-time assessment of cerebral oxygen saturation, allowing for timely interventions to maintain adequate oxygen levels in the brain. Supplemental oxygen increases the amount of oxygen available in the blood, while mechanical ventilation ensures that oxygen is effectively delivered to the lungs and subsequently to the brain. These treatments are vital for preventing brain damage and improving outcomes in patients with cerebral hypoxia by ensuring that the brain receives sufficient oxygen.

What side effects are associated with this type of intervention?

Common treatments for cerebral hypoxia include oxygen therapy, mechanical ventilation, and medications to support blood pressure and cardiac function. Oxygen therapy can cause oxygen toxicity, leading to lung damage and retinopathy, especially in premature infants. Mechanical ventilation may result in ventilator-associated lung injury, infections, and barotrauma. Medications used to support blood pressure and cardiac function, such as vasopressors, can cause arrhythmias, tissue ischemia, and increased cardiac workload. Monitoring cerebral oxygen saturation with NIRS aims to optimize these treatments and minimize their side effects.

What prior FDA approvals exist?

There are no specific FDA-approved treatments mentioned for cerebral hypoxia that directly align with the use of Near-Infrared Spectroscopy (NIRS) monitoring to maintain cerebral oxygen saturation. The Brain Oxygenation-II study is exploring this approach in extremely premature infants, but it appears to be an investigational method rather than an established, FDA-approved treatment. Broadly, treatments for cerebral hypoxia focus on ensuring adequate oxygen delivery and may include supportive measures such as mechanical ventilation and oxygen therapy.

What other types of research exist?

Promising alternatives to NIRS for monitoring cerebral hypoxia include: 1) Functional MRI (fMRI), which provides detailed brain activity mapping and oxygenation levels; 2) Diffuse Optical Tomography (DOT), offering high-resolution imaging of brain oxygenation; and 3) Transcranial Doppler Ultrasound (TCD), which measures cerebral blood flow velocity and can infer oxygenation status. These technologies are advancing and may offer improved monitoring capabilities by 2024.

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Intervention for Brain Hypoxia in Premature Infants (BOx-II Trial)

Phase 2

Waitlist Available

Led By Zachary Vesoulis, MD

Research Sponsored by Valerie Chock, M.D., M.S. Epi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Infants born with postmenstrual age less than 28 weeks

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up birth until hospital discharge, an average of 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial uses near-infrared light to monitor and manage brain oxygen levels in extremely premature infants. The goal is to keep their brain oxygen within a safe range during the first few days of life to prevent serious complications. This method has been increasingly used in specialized hospital units to monitor brain oxygen and prevent long-term issues in preterm infants.

Who is the study for?

The Brain Oxygenation-II study is for extremely premature infants born before 28 weeks of pregnancy. To participate, parents must give written consent and the infant must be able to have a cerebral NIRS oximeter placed within six hours after birth. Infants not receiving full intensive care or with skin issues preventing sensor placement cannot join.

What is being tested?

This trial tests a treatment guideline using near-infrared spectroscopy (NIRS) to keep brain oxygen levels in a target range during the first 72 hours of life in these infants. The goal is to see how well this approach prevents brain hypoxia and its associated risks.

What are the potential side effects?

Since this intervention involves monitoring and maintaining oxygen levels, direct side effects are minimal but may include discomfort from the NIRS oximeter sensor or skin irritation where it's attached.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My baby was born before reaching 28 weeks of pregnancy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ birth until hospital discharge, an average of 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~birth until hospital discharge, an average of 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and birth until hospital discharge, an average of 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Frequency of interventions used to address cerebral hypoxia

Secondary study objectives

Rates of cerebral hypoxia and systemic hypoxia

Rates of death or severe brain injury

Other study objectives

Rates of other neonatal morbidities

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Interventional ArmExperimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for cerebral hypoxia include the use of Near-Infrared Spectroscopy (NIRS) monitoring, supplemental oxygen, and mechanical ventilation. NIRS monitoring helps in real-time assessment of cerebral oxygen saturation, allowing for timely interventions to maintain adequate oxygen levels in the brain. Supplemental oxygen increases the amount of oxygen available in the blood, while mechanical ventilation ensures that oxygen is effectively delivered to the lungs and subsequently to the brain. These treatments are vital for preventing brain damage and improving outcomes in patients with cerebral hypoxia by ensuring that the brain receives sufficient oxygen.