Status:
COMPLETED
An Optical Neuro-monitor of Cerebral Oxygen Metabolism and Blood Flow for Neonatology
Lead Sponsor:
Gorm Greisen
Conditions:
Hemodynamic Instability
Eligibility:
All Genders
Up to 4 years
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 metabol...
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...
Eligibility Criteria
Inclusion
- Setting 1 and 2:
- GA \> 37 weeks
- planned to be delivered by an uncomplicated elective caesarean section
Exclusion
- 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)
Key Trial Info
Start Date :
June 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02815618
Start Date
June 1 2016
End Date
December 1 2022
Last Update
March 28 2023
Active Locations (2)
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1
Rigshospitalet
Copenhagen, Denmark, 2100
2
IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, Italy, 20122