Clinical trial NCT05171881: Brain Oxygenation-II
Official title: Brain Oxygenation in Extremely Preterm Infants-II
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Cerebral Hypoxia
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: Cerebral Palsy Alliance
First posted: 2021-12-29
Enrollment: 100
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm interventional study to maintain cerebral oxygen saturation in targeted range
Primary purpose: DIAGNOSTIC

Brief summary: The Brain Oxygenation-II study (BOx-II) is a phase-II, multicenter, single-arm clinical trial evaluating interventions based on near-infrared spectroscopy (NIRS) monitoring of cerebral oxygen saturation in extremely premature infants. Enrolled infants will follow a treatment guideline to maintain cerebral oxygen saturation in a target range within the first 72 hours of life. The primary outcomes will include interventions used to maintain cerebral saturation in target range, rates of cerebral hypoxia and systemic hypoxia, and a composite of death or severe brain injury detected on term-equivalent magnetic resonance imaging.


Eligibility criteria: Inclusion Criteria:

* Infants born with postmenstrual age less than 28 weeks
* Signed informed consent

Exclusion Criteria:

* Missing written parental informed consent
* Decision not to conduct full intensive care support
* No possibility to place cerebral NIRS oximeter within six hours after birth
* Skin integrity insufficient to allow for sensor placement as deemed by a clinician

Primary outcomes:
measure: Frequency of interventions used to address cerebral hypoxia
timeFrame: From birth until 72 hours of life
Secondary outcomes:
measure: Rates of cerebral hypoxia and systemic hypoxia
timeFrame: From birth until 72 hours of life
measure: Rates of death or severe brain injury
timeFrame: 36-42 weeks corrected gestational age
Other outcomes:
measure: Rates of other neonatal morbidities
timeFrame: Birth until hospital discharge, an average of 3 months
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Saint Louis
country: United States
facility: Washington University in Saint Louis
state: Missouri
city: Dallas
country: United States
facility: University of Texas- Southwestern Medical Center
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Stanford University
name: Valerie Chock, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University in Saint Louis
name: Zachary Vesoulis, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vesoulis Z, Hopper A, Fairchild K, Zanelli S, Chalak L, Noroozi M, Liu J, Chock V. A phase-II clinical trial of targeted cerebral near infrared spectroscopy using standardized treatment guidelines to improve brain oxygenation in preterm infants (BOx-II): A study protocol. Contemp Clin Trials. 2022 Sep;120:106886. doi: 10.1016/j.cct.2022.106886. Epub 2022 Aug 19.