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

March 27, 2023 updated by: Gorm Greisen

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The BabyLux project aims to provide a precise, accurate, and robust device to continuously monitor cerebral oxygen metabolism and blood flow in critically ill newborn infants. This will be achieved by combining time resolved near-infrared spectroscopy (TRS) with newly developed diffuse correlation spectroscopy (DCS) in a single device. The innovative aspects of the project are related to the use of advanced solutions, based on state-of-the-art photonic components, which have already been tested in laboratory and clinical tests on adults.

Time Resolved Near-infrared spectroscopy and Diffuse Correlation Spectroscopy

The proposed solution will integrate two advanced photonic techniques, TRS and DCS. Both techniques rely on the use of an optical fibre probe (sensor) to illuminate with very low power near-infrared light the scalp and to collect the diffusively reflected optical signal that has propagated through the scalp and skull, and therefore carries information on the deeper cortical region. The different absorption spectra of oxygenated and deoxygenated haemoglobin in the near-infrared range allows for the non-invasive monitoring of the two species in the cortical tissue.

TRS and DCS prototypes are available and have been technically tested in laboratory settings and successfully validated during preclinical trials on adult volunteers and patients.

Measured TRS/DCS parameters

TRS measures the attenuation and the temporal broadening of relatively short light pulses (pulse duration ~100 ps) through a diffusive medium (e.g. a neonate's head). TRS has the ability to resolve path-lengths (or equivalently time-of-flights) of photons that have propagated through the tissues. This enables TRS to separate the absorption and scattering coefficients allowing for absolute measurements, and to utilize time-gating of path-lengths to emphasize signals from deeper tissues. This is particularly important for separating intra- and extra-cerebral signals for brain monitoring.

DCS relies on the fact that temporal correlation of light fields in turbid media also obeys a diffusion equation, albeit a slightly different one than is used for TRS. Thus DCS shares the light penetration advantages of TRS, but, since DCS explicitly measures red blood cell movement, it provides a direct measure of quantities such as cerebral blood flow (CBF).

The specific combination of DCS and TRS allows for the assessment of cerebral oxygen metabolism and CBF in a complete (i.e. CBF and oxygenation are simultaneously and independently provided), accurate (i.e. based on absolute measurements of optical parameters) and robust (i.e. potentially less affected by artefacts related to superficial systemic activity or sensor/head movements) way.

The aim of this study is to perform clinical measurements using the BabyLux instrument in different clinical real-life settings to validate this new technology in terms of feasibility, repeatability of measurements, and user friendliness in neonatal medicine.

The BabyLux system is tested in four different real-life settings to measure:

  1. The increase in oxygenation and change in blood flow during the minutes after birth to specify the expected range of measurement;
  2. The precision and repeatability of measurements by reapplying the NIRS sensor several times on slightly different sites of the head in a relatively steady condition;
  3. The cerebral vaso-reactivity to arterial carbon dioxide tension in mechanically ventilated newborns to monitor induced changes in cerebral blood flow;
  4. The user-friendliness and loss of signal in routine care situations (e.g. during 24-hour monitoring of neonates undergoing intensive care).

Study Type

Observational

Enrollment (Actual)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet
  • Italy
      • Milan, Italy, 20122
        • IRCCS Ca'Granda Ospedale Maggiore Policlinico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Setting 1 and 2:

Newborn infants immediately after delivery by elective caesarean and on their second day of life.

Setting 3:

Premature infants on mechanical ventilation.

Setting 4:

Neonate infants on ventilatory support

Description

Setting 1 and 2:

Inclusion Criteria:

  • GA > 37 weeks
  • planned to be delivered by an uncomplicated elective caesarean section

Exclusion Criteria:

  • need for resuscitation or supplementary oxygen during the first 10 minutes following umbilical cord clamping
  • congenital malformations

Setting 3:

Inclusion Criteria:

  • GA < 37 weeks
  • Postnatal age more > 24 hours
  • Mechanically ventilated
  • Clinically stable
  • Normal brain ultrasound
  • Transcutaneous pCO2 monitoring (tcpCO2)

Exclusion Criteria:

  • Congenital malformations

Setting 4:

Inclusion Criteria:

  • Postnatal age < 28 days
  • ventilatory support by mechanical ventilation or nasal CPAP

Exclusion Criteria:

  • Congenital malformations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Infants delivered by elective caesarean
Infants to be measured immediately after birth and on their second day of life.
Device: BabyLux Neuro-monitor
Measurement of cerebral blood flow index (CBFi) and tissue oxygen saturation (StO2).
Infants on mechanical ventilation
Infants to be measured while changing ventilator settings to normalize arterial pCO2.
Device: BabyLux Neuro-monitor
Measurement of cerebral blood flow index (CBFi) and tissue oxygen saturation (StO2).
Infants on ventilatory support
Infants to be measured for 24 hours continuously to assess user-friendliness and loss of signal.
Device: BabyLux Neuro-monitor
Measurement of cerebral blood flow index (CBFi) and tissue oxygen saturation (StO2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral tissue oxygen saturation (StO2) after birth.
Time Frame: 10 min immediately after umbilical cord clamping.
Measurement of cerebral haemodynamics immediately after birth.
10 min immediately after umbilical cord clamping.
Precision and repeatability
Time Frame: During second day of life.
Test-retest variability estimated by within-subject standard deviation in one-way ANOVA with subject as factor.
During second day of life.
Cerebral vaso-reactivity to arterial carbon dioxide
Time Frame: 1 hour after change in ventilator settings.
Mean CBFi and tcpCO2 one minute before the change and 15 min after will be used to analyse CBFi-tcpCO2 reactivity.
1 hour after change in ventilator settings.
Assessment of user-friendliness and loss of signal in routine care
Time Frame: 24 hours of contineous measurements.
Assessed by Likert-scale questionnaire completed by clinical staff.
24 hours of contineous measurements.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gorm Greisen

Investigators

  • Principal Investigator: Gorm Greisen, MD, Prof., Rigshospitalet, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

January 1, 2021

Study Completion (Actual)

December 1, 2022

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 28, 2016

Study Record Updates

Last Update Posted (Actual)

March 28, 2023

Last Update Submitted That Met QC Criteria

March 27, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BabyLux CIP 4.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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