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Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial

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Harvard

Hansen, ML, Pellicer, A, Gluud, C, Dempsey, E, Mintzer, J, Hyttel-Sørensen, S, Heuchan, AM, Hagmann, C, Ergenekon, E, Dimitriou, G, Pichler, G, Naulaers, G, Cheng, G, Guimarães, H, Tkaczyk, J, Kreutzer, KB, Fumagalli, M, Claris, O, Lemmers, P, Fredly, S, Szczapa, T, Austin, T, Jakobsen, JC & Greisen, G 2019, 'Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial' Trials, bind 20, nr. 1, s. 811. https://doi.org/10.1186/s13063-019-3955-6

APA

CBE

Hansen ML, Pellicer A, Gluud C, Dempsey E, Mintzer J, Hyttel-Sørensen S, Heuchan AM, Hagmann C, Ergenekon E, Dimitriou G, Pichler G, Naulaers G, Cheng G, Guimarães H, Tkaczyk J, Kreutzer KB, Fumagalli M, Claris O, Lemmers P, Fredly S, Szczapa T, Austin T, Jakobsen JC, Greisen G. 2019. Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial. Trials. 20(1):811. https://doi.org/10.1186/s13063-019-3955-6

MLA

Vancouver

Author

Hansen, Mathias Lühr ; Pellicer, Adelina ; Gluud, Christian ; Dempsey, Eugene ; Mintzer, Jonathan ; Hyttel-Sørensen, Simon ; Heuchan, Anne Marie ; Hagmann, Cornelia ; Ergenekon, Ebru ; Dimitriou, Gabriel ; Pichler, Gerhard ; Naulaers, Gunnar ; Cheng, Guoqiang ; Guimarães, Hercilia ; Tkaczyk, Jakub ; Kreutzer, Karen B ; Fumagalli, Monica ; Claris, Olivier ; Lemmers, Petra ; Fredly, Siv ; Szczapa, Tomasz ; Austin, Topun ; Jakobsen, Janus Christian ; Greisen, Gorm. / Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants : a protocol for the SafeBoosC randomised clinical phase III trial. I: Trials. 2019 ; Bind 20, Nr. 1. s. 811.

Bibtex

@article{bdf4b3b6020a4995a268b0c817cd47e2,
title = "Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants: a protocol for the SafeBoosC randomised clinical phase III trial",
abstract = "BACKGROUND: Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants.METHODS/DESIGN: SafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using 'opt-out' or deferred consent). Exclusion criteria will be no parental informed consent (or if 'opt-out' is used, lack of a record that clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record of the parents' decision to opt-out in the infant's clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22{\%} relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants.DISCUSSION: Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates.TRIAL REGISTRATION: ClinicalTrial.gov, NCT03770741. Registered 10 December 2018.",
author = "Hansen, {Mathias L{\"u}hr} and Adelina Pellicer and Christian Gluud and Eugene Dempsey and Jonathan Mintzer and Simon Hyttel-S{\o}rensen and Heuchan, {Anne Marie} and Cornelia Hagmann and Ebru Ergenekon and Gabriel Dimitriou and Gerhard Pichler and Gunnar Naulaers and Guoqiang Cheng and Hercilia Guimar{\~a}es and Jakub Tkaczyk and Kreutzer, {Karen B} and Monica Fumagalli and Olivier Claris and Petra Lemmers and Siv Fredly and Tomasz Szczapa and Topun Austin and Jakobsen, {Janus Christian} and Gorm Greisen",
year = "2019",
month = "12",
day = "30",
doi = "10.1186/s13063-019-3955-6",
language = "English",
volume = "20",
pages = "811",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants

T2 - a protocol for the SafeBoosC randomised clinical phase III trial

AU - Hansen, Mathias Lühr

AU - Pellicer, Adelina

AU - Gluud, Christian

AU - Dempsey, Eugene

AU - Mintzer, Jonathan

AU - Hyttel-Sørensen, Simon

AU - Heuchan, Anne Marie

AU - Hagmann, Cornelia

AU - Ergenekon, Ebru

AU - Dimitriou, Gabriel

AU - Pichler, Gerhard

AU - Naulaers, Gunnar

AU - Cheng, Guoqiang

AU - Guimarães, Hercilia

AU - Tkaczyk, Jakub

AU - Kreutzer, Karen B

AU - Fumagalli, Monica

AU - Claris, Olivier

AU - Lemmers, Petra

AU - Fredly, Siv

AU - Szczapa, Tomasz

AU - Austin, Topun

AU - Jakobsen, Janus Christian

AU - Greisen, Gorm

PY - 2019/12/30

Y1 - 2019/12/30

N2 - BACKGROUND: Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants.METHODS/DESIGN: SafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using 'opt-out' or deferred consent). Exclusion criteria will be no parental informed consent (or if 'opt-out' is used, lack of a record that clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record of the parents' decision to opt-out in the infant's clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants.DISCUSSION: Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates.TRIAL REGISTRATION: ClinicalTrial.gov, NCT03770741. Registered 10 December 2018.

AB - BACKGROUND: Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants.METHODS/DESIGN: SafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using 'opt-out' or deferred consent). Exclusion criteria will be no parental informed consent (or if 'opt-out' is used, lack of a record that clinical staff have explained the trial and the 'opt-out' consent process to parents and/or a record of the parents' decision to opt-out in the infant's clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants.DISCUSSION: Treatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates.TRIAL REGISTRATION: ClinicalTrial.gov, NCT03770741. Registered 10 December 2018.

U2 - 10.1186/s13063-019-3955-6

DO - 10.1186/s13063-019-3955-6

M3 - Journal article

VL - 20

SP - 811

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

ER -

ID: 58954239