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Cerebral oxygenation and blood flow in term infants during postnatal transition: BabyLux project
  1. Agnese De Carli1,
  2. Björn Andresen2,
  3. Martina Giovannella3,
  4. Turgut Durduran3,4,
  5. Davide Contini5,
  6. Lorenzo Spinelli6,
  7. Udo Michael Weigel7,
  8. Sofia Passera1,
  9. Nicola Pesenti1,
  10. Fabio Mosca1,8,
  11. Alessandro Torricelli5,6,
  12. Monica Fumagalli1,8,
  13. Gorm Greisen2
  1. 1 Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico-Neonatal Intensive Care Unit, Milan, Italy
  2. 2 Department of Neonatology, Rigshospitalet, Copenhagen, Denmark
  3. 3 ICFO, Institut de Ciències Fotòniques, The Barcelona Institute of Science and Technology, Barcelona, Spain
  4. 4 Institució Catalana de Recerca i Estudis Avançats (ICREA), Barcelona, Spain
  5. 5 Dipartimento di Fisica, Politecnico di Milano, Milan, Italy
  6. 6 Istituto di Fotonica e Nanotecnologie, Consiglio Nazionale delle Ricerche, Milan, Italy
  7. 7 HemoPhotonics S.L., Barcelona, Spain
  8. 8 University of Milan - Department of Clinical Sciences and Community Health, Milan, Italy
  1. Correspondence to Dr Monica Fumagalli, NICU, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan 20122, Italy; monica.fumagalli{at}unimi.it

Abstract

Objectives A new device that combines, for the first time, two photonic technologies (time-resolved near-infrared spectroscopy and diffuse correlation spectroscopy) was provided and tested within the BabyLux project. Aim was to validate the expected changes in cerebral oxygenation and blood flow.

Methods A pulse oximeter and the BabyLux device were held in place (right hand/wrist and frontoparietal region, respectively) for 10 min after birth in healthy term infants delivered by elective caesarean section. Pulse oximeter saturation (SpO2), cerebral tissue oxygen saturation (StO2) and blood flow index (BFI) were measured over time. Tissue oxygen extraction (TOE) and cerebral metabolic rate of oxygen index (CMRO2I) were calculated.

Results Thirty infants were enrolled in two centres. After validity check of data, 23% of infants were excluded from TOE and CMRO2I calculation due to missing data. As expected, SpO2 (estimate 3.05 %/min; 95% CI 2.78 to 3.31 %/min) and StO2 (estimate 3.95 %/min; 95% CI 3.63 to 4.27 %/min) increased in the first 10 min after birth, whereas BFI (estimate −2.84×10−9 cm2/s/min; 95% CI −2.50×10−9 to −3.24×10−9 cm2/s/min) and TOE (estimate −0.78 %/min; 95% CI −1.12 to –0.45 %/min) decreased. Surprisingly, CMRO2I decreased (estimate −7.94×10−8/min; 95% CI −6.26×10−8 to −9.62×10−8/min).

Conclusions Brain oxygenation and BFI during transition were successfully and simultaneously obtained by the BabyLux device; no adverse effects were recorded, and the BabyLux device did not limit the standard care. The preliminary results from clinical application of the BabyLux device are encouraging in terms of safety and feasibility; they are consistent with previous reports on brain oxygenation during transition, although the interpretation of the decreasing CMRO2I remains open.

Trial registration number NCT02815618.

  • near-infrared spectroscopy
  • diffuse correlation spectroscopy
  • tissue oxygen saturation
  • cerebral blood flow
  • term infants
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Footnotes

  • Contributors ADC participated to the design of the work; she managed the enrolment of patients and acquisition of data in Milan, after obtaining technical and ethical local permissions; she gave substantial contributions to the analysis or interpretation of data. She wrote the first draft of the paper, gave final approval of the version published and ensured that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. BA participated to the design of the work; he managed the enrolment of patients and acquisition of data in Copenhagen, after obtaining technical and ethical local permissions; he gave substantial contributions to the analysis or interpretation of data; he revised the work with important intellectual content. He gave final approval of the version published. MG participated to the design of the work; she gave most technical support to the BabyLux device and contributed to the acquisition of data in Copenhagen. She gave substantial contributions to the analysis or interpretation of data, especially those obtained by diffuse correlation spectroscopy; she wrote and revised the work with important intellectual content and gave final approval of the version published. TD participated to the design of the work; he designed and constructed the DCS module giving essential contributions to analysis or interpretation of data. He revised the work with important intellectual content and gave final approval of the version published. DC participated to the design of the work; he gave most technical support to the BabyLux device and contributed to the acquisition of data in Milan. He gave substantial contributions to the analysis or interpretation of data, especially those obtained by time-resolved near-infrared spectroscopy; he wrote and revised the work with important intellectual content and gave final approval of the version published. LS participated to the design of the work; he gave technical support to the BabyLux device and contributed to the acquisition of data in Milan. He gave substantial contributions to the analysis or interpretation of data especially those obtained by time-resolved near-infrared spectroscopy; he wrote and revised the work with important intellectual content and gave final approval of the version published. UMW participated to the design of the work: he drew up the DCS-TRS system customisation and software adaptation to develop the final BabyLux device. He gave essential contributions to the analysis or interpretation of data. He revised the work with important intellectual content and gave final approval of the version published. SP participated to the the enrolment of patients and acquisition of data in Milan; she gave substantial contributions to the analysis or interpretation of data. She revised the work with important intellectual content and gave final approval of the version published. NP participated to the acquisition of data in Milan; he performed the statistical analysis and gave a substantial contribution to the interpretation of data. He wrote and revised the work with important intellectual content and gave final approval of the version published. FM gave a substantial contribution to the conception, design of the work and interpretation of final data. He participated to the intellectual content revision of the work, and he gave his final approval of the published version. AT is the project manager of the BabyLux project. He coordinated and managed the whole project, contributing to the design the clinical protocol. He gave substantial contributions to the acquisition, analysis or interpretation of data. He revised the work critically for important intellectual content, gave final approval of the version published, ensured that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. MF contributed most in the design of the clinical protocol. She supervised and managed the enrolment in Milan, obtained the technical and ethical local permissions and gave a substantial contribution to the acquisition, analysis and interpretation of the data. She wrote and revised the draft giving important technical and intellectual contribution. She gave final approval of the version published and ensured that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved. GG contributed most in the design of the clinical protocol. He supervised the enrolment in Copenhagen, obtained the technical and ethical local permissions and gave a substantial contribution to the analysis and interpretation of the data. He wrote and revised the draft giving important technical and intellectual contribution. He gave final approval of the version published and ensured that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

  • Funding This research was funded by the European Commission Competitiveness for Innovation Program (grant agreement no. 620996) as part of the project ‘An optical neuro-monitor of cerebral oxygen metabolism and blood flow for neonatology (BabyLux)’. We also acknowledge funding from Fundació CELLEX Barcelona and ’Severo Ochoa' Programme (SEV-2015-0522).

  • Competing interests UMW is the CEO, has equity ownership in HemoPhotonics S.L. and is an employee in the company. His role in the project has been defined by the project objectives, tasks and work-packages and was reviewed by the European Commission.

  • Ethics approval Local research ethics committees approved the same study protocol in both centres (Rigshospitalet, Copenhagen, Denmark and Fondazione IRCCS Ca’ Granda, Ospedale Maggiore Policlinico, Milan, Italy).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Patient consent for publication Parental/guardian consent obtained.

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