12/27/2023 0 Comments Statplus paired t testIt was approved by the local ethics committee (J. This was the SafeBoosC pilot study of the experimental arm of the SafeBoosC phase II focusing on the initial 14 days of the planned trial period. The present study was an observational pilot including ten infants in the experimental group. Infants will be randomised to cerebral NIRS oximetry during the first 72 hours of life and a specific treatment guideline versus blinded NIRS monitoring and standard care. The research programme Safeguarding the Brains of our smallest Children (SafeBoosC) phase II trial hypothesizes that the burden of cerebral hypo- and hyperoxia can be reduced by 50% with the further aim to reduce brain injury. SafeBoosC is a research programme aiming to test the benefits and harms of cerebral NIRS oximetry in extremely preterm infants. rStO2 is primarily correlated with venous saturation – and hence with the balance between cerebral oxygen delivery and oxygen consumption, and is an estimate of cerebral blood flow. The regional tissue oxygen saturation of haemoglobin (rStO2) can be estimated in a non-invasive and continuous manner by near-infrared spectroscopy (NIRS). A likely risk factor is fluctuating cerebral blood flow during the transitional phase in the first days of life. Trial registration: : NCT01530360.Īn extremely preterm infant born before 28 weeks of gestation has about 25% risk of surviving with a severe neurodevelopmental deficit. Thus, a revision of the treatment guideline and an alarm system is required.įunding: The Elsass Foundation funded the present study. In all cases, this was unrelated to NIRS monitoring and treatment.Ĭonclusion: The intervention of early cerebral NIRS monitoring proved feasible, but prolonged periods of hypoxia went untreated. Two infants suffered second-degree burns from the sensor. A total of 18 of the 29 interventions were adjustments of FiO2 which in 13 of the 18 times resulted in an out-of-range SpO2. These periods accounted for 72% of the total hypoxia burden. In comparison, there were 83 periods of more than ten minutes with an rStO2 below 55% and four episodes with an rStO2 above 85%. Clinical staff responded to an out of range value 29 times – only once to values above 85%. The median recording time was 69.7 hours, mean rStO2 was 64.2 ± 4.5%, median burden of hyper- and hypoxia was 30.3% hours (range 2.8-112.3). Results: The median gestational age was 26 weeks + three days, and the median start-up time was 133 minutes after delivery. Material and methods: This was an observational study including ten infants. This study was a pilot of the Visible Oximetry Group. The primary outcome is duration multiplied with the extent outside the normal range of regional tissue oxygen saturation of haemoglobin (rStO2) of 55 to 85% in percentage hours (burden). ![]() ![]() In a phase II trial, infants will be randomised to visible cerebral NIRS oximetry with pre-specified treatment guidelines compared to standard care with blinded NIRS-monitoring. Introduction: The research programme Safeguarding the Brains of our smallest Children (SafeBoosC) aims to test the benefits and harms of cerebral near-infrared spectroscopy (NIRS) oximetry in infants born before 28 weeks of gestation. Dempsey5, Monica Fumagalli6,Christian Gluud7, Cornelia Hagmann8, Lena Hellström-Westas9, Petra Lemmers3, Gunnar Naulaers10, Wim van Oeveren11, Adelina Pellicer12,Gerhard Pichler13, Claudia Roll14, Lina Saem Støy7, Martin Wolf15 & Gorm Greisen1 1) Department of Neonatology, Rigshospitalet, Copenhagen, Denmark 2) Department of Paediatrics, Rosie Maternity Hospital, Cambridge, United Kingdom 3) Department of Neonatology, Wilhelmina Children’s Hospital, Utrecht, The Netherlands 4) Depatment of Neonatology, Hospices Civils de Lyon, Lyon, France 5) Department of Neonatology, University College Cork, Cork, Ireland 6) Department of Maternal and Pediatric Sciences, Università di Milano, Milan, Italy 7) Copenhagen Trial Unit, Rigshospitalet, Copenhagen, Denmark 8) Department of Maternal and Pediatric Sciences, University Hospital Zurich, Clinic of Neonatology, Zurich, Switzerland 9) Department of Neonatology, University Hospital Uppsala, Uppsala, Sweden10) Department of Neonatology, Katholieke Universiteit Leuven, Leuven, Belgium11) Haemoscan B.V, Groningen, The Netherlands12) Department of Neonatology, La Paz University Hospital, Madrid, Spain13) Department of Paediatrics, Medical University of Graz, Graz, Austria14) Department of Neonatology and Paediatric Intensive Care, Vest Children’s Hospital Datteln, Germany15) Biomedical Optics Research Laboratory, University Hospital Zurich, Zurich, Switzerland Simon Hyttel-Sørensen1, Topun Austin2, Frank van Bel3, Manon Benders3, Olivier Claris4, Eugene M.
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