An Optical Neuro-monitor of Cerebral Oxygen Metabolism and Blood Flow for Neonatology
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 48
- Locations
- 2
- Primary Endpoint
- Cerebral tissue oxygen saturation (StO2) after birth.
Study Overview
Brief 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:
- Changes in cerebral oxygenation and haemodynamics after birth
- precision and repeatability
- The cerebral vaso-reactivity to arterial carbon dioxide
- Assessment of the user-friendliness and loss of signal in routine care
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
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 4 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
- •Inclusion Criteria:
- •Postnatal age < 28 days
- •ventilatory support by mechanical ventilation or nasal CPAP
- •Exclusion Criteria:
- •Congenital malformations
Outcomes
Primary Outcomes
Cerebral tissue oxygen saturation (StO2) after birth.
Time Frame: 10 min immediately after umbilical cord clamping.
Measurement of cerebral haemodynamics immediately after birth.
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.
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.
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Gorm Greisen
Professor, MD
Rigshospitalet, Denmark