Intervention for Brain Hypoxia in Premature Infants

(BOx-II Trial)

Recruiting at 4 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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Valerie Chock, MD

Principal Investigator

Stanford University

Zachary Vesoulis, MD

Principal Investigator

Washington University in Saint Louis

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+