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Cerebral Saturation Monitoring for Brain Hypoxia in Premature Infants (BOX Trial)

N/A
Waitlist Available
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Less than 6 hours of age
Very preterm infants with gestational age at least 23 weeks but less than 29 completed weeks
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 22-26 months of age
Awards & highlights

BOX Trial Summary

This trial looks at whether targeted cerebral saturation monitoring in extremely premature infants improves neurodevelopmental outcomes.

Who is the study for?
This trial is for very preterm infants less than 6 hours old, born at least 23 but less than 29 weeks gestation. It's not suitable for babies with skin issues preventing NIRS sensor placement, life expectancy-affecting congenital conditions other than premature birth, or those not receiving full intensive care.Check my eligibility
What is being tested?
The study tests if setting target ranges for brain oxygen levels in extremely preterm infants improves their brain development outcomes by age 22-26 months. Infants are randomly assigned to either a group with visible cerebral oxygen readings or a control group with hidden readings.See study design
What are the potential side effects?
Since this trial involves monitoring and clinical algorithms rather than drugs, traditional side effects aren't expected. However, there may be risks associated with the handling of the infants during the application of sensors and adherence to treatment guidelines.

BOX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am less than 6 hours old.
Select...
My baby was born between 23 and 29 weeks of pregnancy.

BOX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~22-26 months of age
This trial's timeline: 3 weeks for screening, Varies for treatment, and 22-26 months of age for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Neurodevelopmental outcome
Secondary outcome measures
Death
Retinopathy of prematurity
Other outcome measures
Burden of Cerebral hypoxia or hyperoxia

BOX Trial Design

2Treatment groups
Active Control
Group I: Non-targeted CsatsActive Control1 Intervention
Subjects randomized to the non-targeted Csat arm will have NIRS (near-infrared spectroscopy) monitoring of Csats, but Csat values will be obscured and not available to providers. These subjects will not have any algorithm-driven clinical interventions for Csat.
Group II: Targeted CsatsActive Control1 Intervention
Subjects randomized to the targeted Csat arm will have NIRS monitoring of cerebral saturations (Csat) and will have algorithm-driven clinical interventions to maintain Csat within target range in the first week of life.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,386 Previous Clinical Trials
17,333,908 Total Patients Enrolled

Media Library

Clinical algorithm Clinical Trial Eligibility Overview. Trial Name: NCT04439968 — N/A
Cerebral Hypoxia Research Study Groups: Non-targeted Csats, Targeted Csats
Cerebral Hypoxia Clinical Trial 2023: Clinical algorithm Highlights & Side Effects. Trial Name: NCT04439968 — N/A
Clinical algorithm 2023 Treatment Timeline for Medical Study. Trial Name: NCT04439968 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently open to enrollees?

"The details on clinicaltrials.gov indicate that this trial is no longer recruiting any volunteers, as the original post was published on August 10th 2021 and has since been updated most recently on November 9th 2022. Nevertheless, 163 other medical trials are still seeking participants at present time."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Neonatal Brain Oxygenation Study
Valerie Chock, M.D., M.S. Epi 2021. "Neonatal Brain Oxygenation Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04439968.
~32 spots leftby Aug 2025
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