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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

BOx-II Trial Summary

This trial is testing whether interventions based on NIRS monitoring can help improve outcomes for extremely premature 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.Check my eligibility
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.See study design
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.

BOx-II Trial 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.

BOx-II Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Frequency of interventions used to address cerebral hypoxia
Secondary outcome measures
Rates of cerebral hypoxia and systemic hypoxia
Rates of death or severe brain injury
Other outcome measures
Rates of other neonatal morbidities

BOx-II 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.

Find a Location

Who is running the clinical trial?

Washington University School of MedicineOTHER
1,945 Previous Clinical Trials
2,303,720 Total Patients Enrolled
Cerebral Palsy AllianceOTHER
7 Previous Clinical Trials
912 Total Patients Enrolled
Valerie Chock, M.D., M.S. EpiLead Sponsor

Media Library

Intervention for cerebral hypoxia Clinical Trial Eligibility Overview. Trial Name: NCT05171881 — Phase 2
Cerebral Hypoxia Research Study Groups: Interventional Arm
Cerebral Hypoxia Clinical Trial 2023: Intervention for cerebral hypoxia Highlights & Side Effects. Trial Name: NCT05171881 — Phase 2
Intervention for cerebral hypoxia 2023 Treatment Timeline for Medical Study. Trial Name: NCT05171881 — Phase 2
~16 spots leftby Dec 2024
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