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An Optical Neuro-monitor of Cerebral Oxygen Metabolism and Blood Flow for Neonatology

NCT02815618 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2023-03-28

No results posted yet for this study

Summary

Feasibility trial on the use of a hybrid optical device integrating time-resolved near-infrared spectroscopy (TRS) and diffuse correlation spectroscopy (DCS) for measurement of cerebral oxygen metabolism and blood flow in neonates.

The device wil be tested in four settings measuring:

1. Changes in cerebral oxygenation and haemodynamics after birth
2. precision and repeatability
3. The cerebral vaso-reactivity to arterial carbon dioxide
4. Assessment of the user-friendliness and loss of signal in routine care

Conditions

  • Hemodynamic Instability

Interventions

DEVICE

BabyLux Neuro-monitor

Measurement of cerebral blood flow index (CBFi) and tissue oxygen saturation (StO2).

Sponsors & Collaborators

  • Gorm Greisen

    lead OTHER

Principal Investigators

  • Gorm Greisen, MD, Prof. · Rigshospitalet, Denmark

Eligibility

Max Age
4 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2021-01-31
Completion
2022-12-31

Countries

  • Denmark
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02815618 on ClinicalTrials.gov