Neonatal Brain Oxygenation Study

NCT04439968 | Active Not Recruiting

• 1 other identifier: 56759
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Hypoxia

Outcome Measures

Primary Outcomes (1)

• Neurodevelopmental outcome

  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.

  22-26 months of age

Secondary Outcomes (2)

• Death

  from birth until hospital discharge, an average of 3 months.

• Retinopathy of prematurity

  from birth until hospital discharge, an average of 3 months.

Other Outcomes (1)

• Burden of Cerebral hypoxia or hyperoxia

  From birth until first 7 days of life

Study Arms (2)

Targeted Csats

ACTIVE COMPARATOR

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.

Other: Clinical algorithm

Non-targeted Csats

NO INTERVENTION

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.

Interventions

Clinical algorithm OTHER

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.

Targeted Csats

Eligibility Criteria

• Age: Up to 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Hypoxia, Brain

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors of neurodevelopmental outcome are blinded to targeted vs non-targeted monitoring
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: randomized to 2 groups: Targeted NIRS monitoring vs Non-targeted, blinded NIRS monitoring

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 19, 2020
• Study Start: August 10, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

US (1)