Back to resultsNeonatal Brain Oxygenation Study (BOX)
Primary Purpose
Cerebral Hypoxia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Clinical algorithm
Sponsored by
About this trial
This is an interventional diagnostic trial for Cerebral Hypoxia
Eligibility Criteria
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
Sites / Locations
- Lucile Packard Children's Hospital Stanford
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Targeted Csats
Non-targeted Csats
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Death
Death prior to hospital discharge
Retinopathy of prematurity
Occurrence of retinopathy of prematurity prior to hospital discharge
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04439968
Brief Title
Neonatal Brain Oxygenation Study
Acronym
BOX
Official Title
Targeted Cerebral Saturations in Extremely Preterm Infants
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 10, 2021 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebral Hypoxia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
randomized to 2 groups: Targeted NIRS monitoring vs Non-targeted, blinded NIRS monitoring
Masking
Outcomes Assessor
Masking Description
Assessors of neurodevelopmental outcome are blinded to targeted vs non-targeted monitoring
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Targeted Csats
Arm Type
Active Comparator
Arm 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.
Arm Title
Non-targeted Csats
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Clinical algorithm
Intervention Description
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.
Primary Outcome Measure Information:
Title
Neurodevelopmental outcome
Description
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.
Time Frame
22-26 months of age
Secondary Outcome Measure Information:
Title
Death
Description
Death prior to hospital discharge
Time Frame
from birth until hospital discharge, an average of 3 months.
Title
Retinopathy of prematurity
Description
Occurrence of retinopathy of prematurity prior to hospital discharge
Time Frame
from birth until hospital discharge, an average of 3 months.
Other Pre-specified Outcome Measures:
Title
Burden of Cerebral hypoxia or hyperoxia
Description
Burden of cerebral hypoxia or hyperoxia from NIRS measures
Time Frame
From birth until first 7 days of life
10. Eligibility
Sex
All
Maximum Age & Unit of Time
2 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Lucile Packard Children's Hospital Stanford
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Neonatal Brain Oxygenation Study
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