Hemodynamic InstabilityBabyLuxNCT02815618
An Optical Neuro-monitor of Cerebral Oxygen Metabolism and Blood Flow for Neonatology
An observational study of Hemodynamic Instability, run by Gorm Greisen at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 4 weeks
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- BabyLux Neuro-monitor
- Type of treatment
- Medical device
- How many people
- 48 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2016to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 weeks
- All sexes
- No healthy volunteers
- Child
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
Who may be able to join
- GA > 37 weeks
- planned to be delivered by an uncomplicated elective caesarean section
- GA < 37 weeks
- Postnatal age more > 24 hours
- Mechanically ventilated
- Clinically stable
Show all 10Show fewer
- Normal brain ultrasound
- Transcutaneous pCO2 monitoring (tcpCO2)
- Postnatal age < 28 days
- ventilatory support by mechanical ventilation or nasal CPAP
Who cannot join
- need for resuscitation or supplementary oxygen during the first 10 minutes following umbilical cord clamping
- congenital malformations
- Setting 3:
- Congenital malformations
- Setting 4:
- Congenital malformations
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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:
- The increase in oxygenation and change in blood flow during the minutes after birth to specify the expected range of measurement;
- 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;
- The cerebral vaso-reactivity to arterial carbon dioxide tension in mechanically ventilated newborns to monitor induced changes in cerebral blood flow;
- The user-friendliness and loss of signal in routine care situations (e.g. during 24-hour monitoring of neonates undergoing intensive care).
- Conditions
- Hemodynamic Instability
- Being tested
- BabyLux Neuro-monitor
- Keywords
- Time-resolved spectroscopy, Diffuse correlation spectroscopy, Neonatology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BabyLux Neuro-monitorDevice
Measurement of cerebral blood flow index (CBFi) and tissue oxygen saturation (StO2).
| Study group | Role | What they receive |
|---|---|---|
| Infants delivered by elective caesarean | Infants to be measured immediately after birth and on their second day of life. Receives: Device: BabyLux Neuro-monitor | |
| Infants on mechanical ventilation | Infants to be measured while changing ventilator settings to normalize arterial pCO2. Receives: Device: BabyLux Neuro-monitor | |
| Infants on ventilatory support | Infants to be measured for 24 hours continuously to assess user-friendliness and loss of signal. Receives: Device: BabyLux Neuro-monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral tissue oxygen saturation (StO2) after birth.
Measurement of cerebral haemodynamics immediately after birth.
Measured: 10 min immediately after umbilical cord clamping.
Precision and repeatability
Test-retest variability estimated by within-subject standard deviation in one-way ANOVA with subject as factor.
Measured: During second day of life.
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.
Measured: 1 hour after change in ventilator settings.
Assessment of user-friendliness and loss of signal in routine care
Assessed by Likert-scale questionnaire completed by clinical staff.
Measured: 24 hours of contineous measurements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionJan 2021
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gorm Greisen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gorm Greisen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gorm Greisen, MD, Prof., Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02815618
- Sponsor's protocol ID
- BabyLux CIP 4.1
- Acronym
- BabyLux
- Status last verified
- Mar 2023
- First submitted
- 23 Jun 2016
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Optical Neuro-monitor of Cerebral Oxygen Metabolism and Blood Flow for Neonatology
- ClinicalTrials.gov ID
- NCT02815618
- Acronym / sponsor ID
- BabyLux / BabyLux CIP 4.1
- Conditions
- Hemodynamic Instability
- Keywords
- Time-resolved spectroscopy, Diffuse correlation spectroscopy, Neonatology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Gorm GreisenUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- Jan 2021 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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:
- The increase in oxygenation and change in blood flow during the minutes after birth to specify the expected range of measurement;
- 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;
- The cerebral vaso-reactivity to arterial carbon dioxide tension in mechanically ventilated newborns to monitor induced changes in cerebral blood flow;
- The user-friendliness and loss of signal in routine care situations (e.g. during 24-hour monitoring of neonates undergoing intensive care).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Infants delivered by elective caesarean | – | Device: BabyLux Neuro-monitorInfants to be measured immediately after birth and on their second day of life. |
| Infants on mechanical ventilation | – | Device: BabyLux Neuro-monitorInfants to be measured while changing ventilator settings to normalize arterial pCO2. |
| Infants on ventilatory support | – | Device: BabyLux Neuro-monitorInfants to be measured for 24 hours continuously to assess user-friendliness and loss of signal. |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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
Key inclusion criteria (10 listed)
- GA > 37 weeks
- planned to be delivered by an uncomplicated elective caesarean section
- GA < 37 weeks
- Postnatal age more > 24 hours
- Mechanically ventilated
Key exclusion criteria (6 listed)
- need for resuscitation or supplementary oxygen during the first 10 minutes following umbilical cord clamping
- congenital malformations
- Congenital malformations
- Congenital malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BabyLux Neuro-monitorMeasurement of cerebral blood flow index (CBFi) and tissue oxygen saturation (StO2). | Device | Infants delivered by elective caesarean, Infants on mechanical ventilation, Infants on ventilatory support |
Primary outcome
Cerebral tissue oxygen saturation (StO2) after birth.
Time frame: 10 min immediately after umbilical cord clamping.
Measurement of cerebral haemodynamics immediately after birth.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Derived from this study: PubMed 31085677De 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.
- The BabyLux project web-siteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gorm Greisen, MD, Prof. principal investigator
Copenhagen University Hospital, Rigshospitalet
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemodynamic Instability, run by Gorm Greisen at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral tissue oxygen saturation (StO2) after birth. (time frame: 10 min immediately after umbilical cord clamping.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02815618, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.