Cerebral NIRS Monitoring During Anesthesia in Neonates an... | NCT04132414

Studies
Cerebral NIRS Monitoring During Anesthesia in Neonates and Infants

NCT04132414

Sponsor

Medical University of Graz

Status

Withdrawn

Last Update Posted

Sep 29, 2025Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Cerebral Oxygenation

Interventions

NIRS open

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study investigators changed institution

Expanded Access Info

Start Date

Dec 2022Estimated

Primary Completion Date

Jun 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Sep 5, 2019

First Submission Date that Met QC Criteria

Oct 16, 2019

First Posted Date

Oct 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2025

Last Update Posted Date

Sep 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NIRS open	Experimental	Cerebral NIRS monitoring applied and visible to caregiver. Interventions according to protocol in phases of cerebral hypoxia	Diagnostic Test: NIRS open
NIRS blinded	No Intervention	NIRS monitoring applied and masked for caregiver.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
NIRS open	Diagnostic Test	Treatment according to protocol in phases of cerebral hypoxia.	NIRS open

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cerebral hypoxic burden	Time under 65% cerebral oxygen saturation	1 day

Secondary Outcomes

Measure	Description	Time Frame
Fluid administration	ml/kg	1 day
Number of participants with Vasopressor or Inotrope administered	Proportion	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

6 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Heschl, M.D., Ph.D.	Medical University of Graz	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided