NCT04439968

Neonatal Brain Oxygenation Study

Targeted Cerebral Saturations in Extremely Preterm Infants

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 2 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Cerebral Hypoxia

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2021-08-10
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2020-06-19
• Last updated: 2024-04-18

Locations

1 site across 1 country: United States