Neonatal Brain Oxygenation Study (BOX)

Stanford University

Status: Active, not recruiting

Conditions: Cerebral Hypoxia

Treatments: Other: Clinical algorithm

Study type: Interventional

Funder types: Other

Identifiers

NCT04439968

56759

Details and patient eligibility

About

Implementing target ranges for regional cerebral saturations in extremely preterm infants in the first week of life may improve neurodevelopmental outcomes at 22-26 months corrected age compared to those without targeted cerebral saturations (Csat) using near-infrared spectroscopy (NIRS). Infants will be randomized to a targeted cerebral saturation monitoring group with visible reading of Csat or to a control group with cerebral saturation monitoring, but with blinded Csat measures. Those in the targeted Csat group will follow a treatment guideline to maintain cerebral oxygenation in the target range. The primary outcome is neurodevelopmental outcome as determined by Bayley III cognitive scale score.

Enrollment: 100 patients

Sex: All

Ages: Under 2 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Very preterm infants with gestational age at least 23 weeks but less than 29 completed weeks
• Less than 6 hours of age

Exclusion criteria

• Skin integrity insufficient to allow placement of NIRS sensors
• Decision not to provide full intensive care support
• Congenital condition, other than premature birth, that adversely affects life expectancy or neurodevelopment

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Targeted Csats

Active Comparator group

Description:

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.

Treatment:

Other: Clinical algorithm

Non-targeted Csats

No Intervention group

Description:

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.