The Light That Brightens the Lives of Premature Babies

Hybrid TRS/DCS sensor (Source: Fh. IPT)

The first results obtained in the framework of the European project BabyLux are encouraging. As a part of the protocol, sixty measurements have been performed with 35 babies enrolled during their first days of life at the Copenhagen Rigshospitalet and the Milanese Ospedale Maggiore Policlinico.

The new optical diagnostic system, developed jointly by nine partners from four European countries within only three years, allows continuous and non-invasive monitoring of brain perfusion and oxygenation, which is still lacking on the market.

The measuring probe is placed on the skin of the baby’s head and works with parallel measurements using two spectroscopic methods, time-resolved spectroscopy, TRS, and diffuse correlation spectroscopy, DCS. In this way, the oxygen supply in the brain can be monitored non-invasively and permanently, without leaving visible traces on the sensitive baby skin. The device is safe with regards to acute adverse reactions, can be brought to the bedside, and allows for continuous monitoring, both under critical and noncritical conditions, as each measurement takes only a few minutes.

This first trial phase was focused on the evaluation of test/re-test variability as a precision benchmark. The tests revealed that moving the sensor from one site to another on the head resulted in a variability of less than 5 % in microvascular blood oxygenation values and in a 15 to 25 % variability in microvascular cerebral blood flow indexes. These values are better than or comparable with currently existing commercial devices (i.e. trans-cranial Doppler ultrasound measures of microvasculature or xenon clearance).

The goal of BabyLux is to reduce the risk of brain lesions in extremely preterm babies and thus prevent disabilities in such children by controlling the clinical parameters affecting their cerebral status with a high level of accuracy. According to the last the Global Action Report published by The World Health Organization, 13 million births every year are preterm. If the new measuring instrument is approved and can be established in the premature infants, an estimate of the researchers alone in Europe could save more than 1000 children per year from the consequences of an under-supply or over-supply of oxygen.

The Fraunhofer Institute for Production Technology IPT in Aachen developed a compact fiber-based probe for the system, which enables parallel measurements using two spectroscopy methods. PicoQuant dealt with the development of specially pulsed diode lasers and a very sensitive, time-resolved detection of the laser light components, which are absorbed as well as back-scattered by the blood.

The integration of these components into a clinic-friendly overall system was subsequently carried out by the Spanish project partner Hemophotonics SL, who is responsible for the commercialization of the system.

In the coming months, another series of measurements will be held to consolidate the results of the clinical trials and to bring the new measuring instrument to the market.

Alessandro Torricelli, coordinator of the BabyLux project and associate professor at the Department of Physics of the Politecnico di Milano, is pleased with the successful completion of the project: “The hope for this project is to pave the way to have this instrument on the market in some years, to provide neonatologists and hospitals with a tool to closely monitor the health of premature babies. In this way, we can enable early-born infants to closely monitor the health of our babies and to protect them from serious damage.”

The BabyLux project was carried out by an international consortium involving the Politecnico di Milano, the Fondazione Politecnico di Milano, the ICFO-Institute of Photonic Sciences, the Fraunhofer Institute for Production Technology IPT, Hemophotonics SL, PicoQuant GmbH, the strategy consultancy Loop Unique Companies, Capital Region, and the Fondazione IRCCS Ca’ Granda – Ospedale Maggiore Policlinico. The consortium proposed and developed an innovative technique for detecting and monitoring the brain oxygenation and perfusion state of newborns in a non-invasive and accurate way. The three year project concluded in April 2017 and was partially funded by the European Commission under the ICT Policy Support Programme (ICT PSP) as part of the Competitiveness and Innovation Framework Program. (Source: Fh. IPT)

Links: BabyLux project, Politecnico di Milano, Italy • Dept. Production metrology (N. König), Fraunhofer Institute for Production Technology IPT; Aachen, Germany • PicoQuant GmbH, Berlin, Germany

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