Neonatal Brain Oxygenation Study

Not Applicable

Active, not recruiting

• Conditions: Cerebral Hypoxia
• Interventions: Other: Clinical algorithm

• Registration Number: NCT04439968
• Lead Sponsor: Stanford University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-15
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-19
• Study Start: 2021-08-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-16
• Last Update Posted: 2024-04-18
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Targeted Csats	Clinical algorithm	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.

Primary Outcome Measures

Name	Time	Method
Neurodevelopmental outcome	22-26 months of age	Neurodevelopmental outcomes will be assessed using the cognitive component of the Bayley Scales of Infant Development-III at 22-26 months of age. Scores range from 55-145 with higher number representing a better neurodevelopmental outcome.

Secondary Outcome Measures

Name	Time	Method
Death	from birth until hospital discharge, an average of 3 months.	Death prior to hospital discharge
Retinopathy of prematurity	from birth until hospital discharge, an average of 3 months.	Occurrence of retinopathy of prematurity prior to hospital discharge

Trial Locations

Locations (1)

Lucile Packard Children's Hospital Stanford; 🇺🇸 Palo Alto, California, United States