NCT04132414

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2022

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
3.1 years until next milestone

Study Start

First participant enrolled

December 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

September 29, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

September 5, 2019

Last Update Submit

September 23, 2025

Conditions

Cerebral Oxygenation

Outcome Measures

Primary Outcomes (1)

  • Cerebral hypoxic burden

    Time under 65% cerebral oxygen saturation

    1 day

Secondary Outcomes (4)

  • Fluid administration

    1 day

  • Number of participants with Vasopressor or Inotrope administered

    1 day

  • Number of participants with erythrocyte administration

    1 day

  • Fraction of inspired oxygen

    1 day

Study Arms (2)

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

NIRS openDIAGNOSTIC_TEST

Treatment according to protocol in phases of cerebral hypoxia.

NIRS open

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Stefan Heschl, M.D., Ph.D.

    Medical University of Graz

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2019

First Posted

October 18, 2019

Study Start

December 1, 2022

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

September 29, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share