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CompletedNCT02815618BabyLuxUpdated Mar 28, 2023

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

An observational study in Hemodynamic Instability, sponsored by Gorm Greisen. Completed at 2 sites in 2 countries. Open to participants aged Up to 4 Weeks. Per ClinicalTrials.gov, last updated 2023-03-28.

Sponsored by Gorm Greisen · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
48
Ages
Up to 4 Weeks
Sex
All
01

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
Read the 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).
02

Conditions studied

  • Hemodynamic Instability

Keywords

  • Time-resolved spectroscopy
  • Diffuse correlation spectroscopy
  • Neonatology
03

In context

Lead sponsor

Gorm Greisen is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 4 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
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

Eligibility criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
48 participants (actual)
Patient registry
No

Groups and cohorts

  • Infants delivered by elective caesarean

    Infants to be measured immediately after birth and on their second day of life.

    Device: BabyLux Neuro-monitor

  • Infants on mechanical ventilation

    Infants to be measured while changing ventilator settings to normalize arterial pCO2.

    Device: BabyLux Neuro-monitor

  • Infants on ventilatory support

    Infants to be measured for 24 hours continuously to assess user-friendliness and loss of signal.

    Device: BabyLux Neuro-monitor

Interventions

  • DeviceBabyLux Neuro-monitor

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

06

What researchers measure

Primary outcomes

  1. Cerebral tissue oxygen saturation (StO2) after birth.

    Measurement of cerebral haemodynamics immediately after birth.

    Time frame: 10 min immediately after umbilical cord clamping.

  2. Precision and repeatability

    Test-retest variability estimated by within-subject standard deviation in one-way ANOVA with subject as factor.

    Time frame: During second day of life.

  3. Cerebral vaso-reactivity to arterial carbon dioxide

    Mean CBFi and tcpCO2 one minute before the change and 15 min after will be used to analyse CBFi-tcpCO2 reactivity.

    Time frame: 1 hour after change in ventilator settings.

  4. Assessment of user-friendliness and loss of signal in routine care

    Assessed by Likert-scale questionnaire completed by clinical staff.

    Time frame: 24 hours of contineous measurements.

07

Study locations

2 sites
  • Rigshospitalet
    Copenhagen, 2100, Denmark
  • IRCCS Ca'Granda Ospedale Maggiore Policlinico
    Milan, 20122, Italy
08

References and documents

Publications

  • De Carli A, Andresen B, Giovannella M, Durduran T, Contini D, Spinelli L, Weigel UM, Passera S, Pesenti N, Mosca F, Torricelli A, Fumagalli M, Greisen G. Cerebral oxygenation and blood flow in term infants during postnatal transition: BabyLux project. Arch Dis Child Fetal Neonatal Ed. 2019 Nov;104(6):F648-F653. doi: 10.1136/archdischild-2018-316400. Epub 2019 May 13. PubMed 31085677 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 28, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02815618
Lead sponsor
Gorm Greisen
Responsible party
Gorm Greisen (Professor, MD, Rigshospitalet, Denmark) — Sponsor-investigator
First posted
Jun 28, 2016
Start date
Jun 2016
Primary completion
Jan 2021
Completion
Dec 2022
Last update
Mar 28, 2023

Study contacts

Gorm Greisen, MD, Prof.
principal investigator · Rigshospitalet, Denmark

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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