Neonatal Brain Oxygenation Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-10

Study Completion Date

2025-12-31

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.

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Detailed Description

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Conditions

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Cerebral Hypoxia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Assessors of neurodevelopmental outcome are blinded to targeted vs non-targeted monitoring

Study Groups

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Targeted Csats

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.

Group Type ACTIVE_COMPARATOR

Clinical algorithm

Intervention Type 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.

Non-targeted Csats

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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

Maximum Eligible Age

2 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No