Brain Oxygenation-II

Cerebral Hypoxia Clinical Trial

— BOx-II  

Official title:

Brain Oxygenation in Extremely Preterm Infants-II

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05171881
• Other study ID #: 56759b
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: April 7, 2022
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: April 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Hours

Eligibility

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

Related Conditions & MeSH terms

• Cerebral Hypoxia
• Hypoxia
• Hypoxia, Brain

Intervention

Other:
• Intervention for cerebral hypoxia
For cerebral oxygen saturation measures below target range (cerebral hypoxia), a treatment algorithm with the following potential clinical interventions will be applied: fluid resuscitation, initiation of vasopressor/inotrope medication, change in mechanical ventilation or respiratory support, adjustment of fractional inspired oxygen, transfusion of red blood cells, acquisition of echocardiogram or cranial ultrasound.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	University of Texas- Southwestern Medical Center	Dallas	Texas
United States	Loma Linda University	Loma Linda	California
United States	Stanford University	Palo Alto	California
United States	Washington University in Saint Louis	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Valerie Chock, M.D., M.S. Epi	Cerebral Palsy Alliance, Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rates of other neonatal morbidities	Rates of other neonatal morbidities including bronchopulmonary dysplasia, severe retinopathy of prematurity, and/or mortality before neonatal intensive care unit discharge	Birth until hospital discharge, an average of 3 months
Primary	Frequency of interventions used to address cerebral hypoxia	Frequency of specific interventions chosen to address cerebral hypoxia	From birth until 72 hours of life
Secondary	Rates of cerebral hypoxia and systemic hypoxia	Rates of cerebral hypoxia as detected by near-infrared spectroscopy (NIRS) monitoring of cerebral oxygen saturation and systemic hypoxia as detected by conventional pulse oximetry monitoring of systemic oxygen saturation	From birth until 72 hours of life
Secondary	Rates of death or severe brain injury	Rates of death or severe brain injury (including intraventricular hemorrhage, white matter injury, cystic periventricular leukomalacia, cerebellar hemorrhage, post-hemorrhagic ventricular dilation, or cerebral atrophy) detected on term-equivalent magnetic resonance imaging performed between 36 and 42 weeks corrected gestational age.	36-42 weeks corrected gestational age