Cerebral NIRS Monitoring During Anesthesia in Neonates and Infants

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

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-31

Study Completion Date

2023-12-31

Brief Summary

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The brain is a very vulnerable organ, especially in premature babies, newborns and infants. However, during anesthesia, the oxygenation of the brain can only be monitored indirectly and insufficiently. Near-infrared spectroscopy (NIRS) is an established monitoring method in other areas (e.g., neonatology, cardiac anesthesia), which provides non-invasive information about the regional oxygen supply of the brain. The integration of this monitoring device into the anaesthesiological care for neonates and infants could reduce the risk of cerebral hypoxia. The planned study investigates whether the use of NIRS in anesthetized children up to 6 months can prevent or influence the occurrence of cerebral hypoxia.

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Detailed Description

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Conditions

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Cerebral Oxygenation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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NIRS open

Cerebral NIRS monitoring applied and visible to caregiver. Interventions according to protocol in phases of cerebral hypoxia

Group Type EXPERIMENTAL

NIRS open

Intervention Type DIAGNOSTIC_TEST

Treatment according to protocol in phases of cerebral hypoxia.

NIRS blinded

NIRS monitoring applied and masked for caregiver.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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NIRS open

Treatment according to protocol in phases of cerebral hypoxia.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Expected duration of Anesthesia \>45 minutes
* Intervention/surgery in the operating room

Exclusion Criteria

* Impossibility to place cerebral NIRS sensor
* Known cerebral pathology
* Missing parental consent
* Congenial cardiac condition with right to left shunt
* Cardiac surgery

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No