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Neonatal Brain Oxygenation Study
Sponsor: Stanford University
Summary
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.
Official title: Targeted Cerebral Saturations in Extremely Preterm Infants
Key Details
Gender
All
Age Range
Any - 2 Days
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2021-08-10
Completion Date
2025-12-31
Last Updated
2024-04-18
Healthy Volunteers
No
Conditions
Interventions
Clinical algorithm
In order to maintain cerebral saturations within targeted range, subjects in the targeted Csat arm will undergo clinical interventions based on clinical algorithm. Interventions may include administration of inotropes, fluid resuscitation, transfusion of blood products, and/or adjustment to respiratory support.
Locations (1)
Lucile Packard Children's Hospital Stanford
Palo Alto, California, United States