Neonatal Brain Oxygenation Study

Study Overview
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Brief Summary
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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
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Targeted Cerebral Saturations in Extremely Preterm Infants

Conditions
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Cerebral Hypoxia

Intervention / Treatment
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* Other: Clinical algorithm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized to 2 groups: Targeted NIRS monitoring vs Non-targeted, blinded NIRS monitoring
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Targeted Csats<br>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<br>* 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.<br>|
| No Intervention: Non-targeted Csats<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death | Death prior to hospital discharge | from birth until hospital discharge, an average of 3 months. | 
| Retinopathy of prematurity | Occurrence of retinopathy of prematurity prior to hospital discharge | from birth until hospital discharge, an average of 3 months. |