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Cerebral NIRS Monitoring During Anesthesia in Neonates and Infants

Monitoring Of REgional Cerebral Oxygenation (rcSO2 ) With Near INFrared SpectrOscopy (NIRS) During Non-cardiac Surgery in Preterms, Neonates and Infants in Addition to Standard Monitoring to Guide Intraoperative Management

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04132414
Enrollment
0
Registered
2019-10-18
Start date
2022-12-31
Completion date
2023-12-31
Last updated
2025-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Oxygenation

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.

Interventions

DIAGNOSTIC_TESTNIRS open

Treatment according to protocol in phases of cerebral hypoxia.

Sponsors

Medical University of Graz
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
No minimum to 6 Months
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cerebral hypoxic burden1 dayTime under 65% cerebral oxygen saturation

Secondary

MeasureTime frameDescription
Fluid administration1 dayml/kg
Number of participants with Vasopressor or Inotrope administered1 dayProportion
Number of participants with erythrocyte administration1 dayProportion
Fraction of inspired oxygen1 day%

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026