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Intervention for Brain Hypoxia in Premature Infants (BOx-II Trial)
Phase 2
Recruiting
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 belowSelect...
My baby was born before reaching 28 weeks of pregnancy.
BOx-II Trial 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
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
1,931 Previous Clinical Trials
2,299,609 Total Patients Enrolled
Cerebral Palsy AllianceOTHER
7 Previous Clinical Trials
912 Total Patients Enrolled
Valerie Chock, M.D., M.S. EpiLead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My baby was born before reaching 28 weeks of pregnancy.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.Your skin is not healthy enough for a sensor to be placed, as determined by a doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Interventional Arm
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Can new patients join this trial right now?
"The most recent update on clinicaltrials.gov shows that this study is looking for participants. This trial was first advertised on April 7th, 2020 and was last updated yesterday."
Answered by AI
Is there a high level of risk associated with the Intervention for cerebral hypoxia?
"While there is data supporting the safety of Intervention for cerebral hypoxia, it only received a score of 2 because there are no studies yet that confirm its efficacy."
Answered by AI
In how many facilities is this research being conducted?
"Including Stanford University in Palo Alto and the University of Virginia in Charlottesville, there are a total of 5 institutions running this trial."
Answered by AI
How many guinea pigs are helping researchers with this clinical trial?
"That is accurate, the clinical trial in question is recruiting patients as of now. This specific trial was first posted on 4/7/2022 and updated for the last time on 5/6/2022. They are looking to enroll 100 total patients from 5 unique sites."
Answered by AI
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