Intervention for Brain Hypoxia in Premature Infants

(BOx-II Trial)

Not currently recruiting at 5 trial locations

Overseen By Valerie Chock, MD

Age: < 18

Sex: Any

Trial Phase: Phase 2

Sponsor: Valerie Chock, M.D., M.S. Epi

Disqualifiers: No intensive care, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 72 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist extremely premature infants at risk of cerebral hypoxia. The treatment uses a special monitor to track brain oxygen levels, guiding doctors to maintain healthy levels during the first three days of life. The goal is to reduce the risk of brain injury or serious health issues. The trial seeks infants born before 28 weeks of pregnancy. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group of infants, providing an opportunity to contribute to important research.

Do I need to stop my current medications for the trial?

The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention is safe for premature infants?

Research has shown that cerebral oximetry, a method to check brain oxygen levels, has been studied in very premature babies. One study found that monitoring and adjusting treatment based on these oxygen levels did not reduce the risk of death or severe brain injury. However, the SafeBoosC-II trial found that this method helped maintain more stable brain oxygen levels.

While some studies have reported death rates in babies using this monitoring, these findings are part of broader research exploring the benefits and risks. Overall, cerebral oximetry appears to be a well-accepted method for managing brain oxygen levels in premature infants, aiming to create a more stable environment for their developing brains. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a non-invasive approach to managing cerebral hypoxia in premature infants, using NIRS monitoring to track brain oxygen levels. Unlike traditional methods that may involve invasive procedures or delayed responses to hypoxia, this technique uses real-time data to guide interventions, aiming for immediate stabilization of oxygen levels. This approach could potentially offer a safer, more responsive way to protect the delicate brains of preterm infants during their critical early days.

What evidence suggests that this intervention is effective for brain hypoxia in premature infants?

Research has shown that using near-infrared spectroscopy (NIRS) to monitor brain oxygen levels in very premature babies can help maintain stability. In this trial, infants in the interventional arm will undergo non-invasive NIRS monitoring of cerebral oxygen saturation, with algorithm-driven clinical interventions to keep levels within the target range during the first 72 hours of life. The SafeBoosC-II study found that this method stabilized brain oxygen levels, ensuring a consistent oxygen supply to the brain, which is crucial in the early days. Although the SafeBoosC-III trial did not find significant differences in outcomes like death or severe brain injury compared to regular care, maintaining stable oxygen levels is still considered beneficial for the overall health of these infants. ^{1 3 6 7 8}

Who Is on the Research Team?

Zachary Vesoulis, MD

Principal Investigator

Washington University in Saint Louis

Valerie Chock, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My baby was born before reaching 28 weeks of pregnancy.

Signed informed consent

Exclusion Criteria

A brain oxygen monitor was not placed on me within six hours after birth.

I have chosen not to receive all possible intensive care treatments.

Missing written parental informed consent

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Infants undergo NIRS monitoring and algorithm-driven interventions to maintain cerebral oxygen saturation within the first 72 hours of life

72 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including rates of neonatal morbidities until hospital discharge

3 months

Long-term follow-up

Rates of death or severe brain injury are assessed using MRI between 36 and 42 weeks corrected gestational age

6 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intervention for cerebral hypoxia

Trial Overview 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.

How Is the Trial Designed?

Group I: Interventional Arm Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Valerie Chock, M.D., M.S. Epi

Lead Sponsor

Trials

1

Recruited

100+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Cerebral Palsy Alliance

Collaborator

Trials

8

Recruited

1,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30144709/

Outcomes of preterm infants treated with hypothermia for ... Four infants died before or soon after discharge (18.2%). Eighteen surviving infants (69.2%) had follow up data; 7 of them had moderate to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11228907/

The SafeBoosC-III trial and the future of cerebral oximetry ... The combined outcome of death or severe brain injury at 36 weeks PMA was 35.2% for cerebral oximetry and 34% for usual clinical care (RR =1.03; ...

3. medrxiv.org medrxiv.org/content/10.1101/2025.10.21.25338440v1.full.pdf

Cerebral Oxygenation Stability In Extremely Preterm Infants The SafeBoosC-II study previously demonstrated significantly improved stability of cerebral oxygenation from the intervention.10 In SafeBoosC-II ...

4. nature.com nature.com/articles/s41390-025-04387-1

Cumulative caffeine exposure predicts ... Preterm infants who receive caffeine for apnea of prematurity have improved neurodevelopmental outcomes compared to untreated infants.

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa2119660

Trial of Erythropoietin for Hypoxic–Ischemic ... The administration of erythropoietin to newborns undergoing therapeutic hypothermia for hypoxic–ischemic encephalopathy did not result in a lower risk of death ...

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2207554

Cerebral Oximetry Monitoring in Extremely Preterm Infants Treatment guided by cerebral oximetry monitoring for the first 72 hours after birth was not associated with a lower incidence of death or severe brain injury.

7. tp.amegroups.org tp.amegroups.org/article/view/125950/html

The SafeBoosC-III trial and the future of cerebral oximetry ... Death rates were 21.2% in the cerebral oximetry group and 19.8% in the usual care group [relative risk (RR) =1.07; 95% confidence interval (CI): ...

8. nature.com nature.com/articles/s41390-023-02895-6

Neuroprotective therapies in the NICU in preterm infants The use of antenatal corticosteroids has strong short-term benefits and most likely improves the neurodevelopmental outcomes of preterm neonates ...