The SafeBoosC Phase II Randomised Clinical Trial: A Treatment Guideline for Targeted Near-Infrared-Derived Cerebral Tissue Oxygenation versus Standard Treatment in Extremely Preterm Infants

Adelina Pellicer; Gorm Greisen; Manon Benders; Olivier Claris; Eugene Dempsey; Monica Fumagalli; Christian Gluud; Cornelia Hagmann; Lena Hellstroem-Westas; Simon Hyttel-Sorensen; Petra Lemmers; Gunnar Naulaers; Gerhard Pichler; Claudia Roll; Frank van Bel; Wim van Oeveren; Maria Skoog; Martin Wolf; Topun Austin; SafeBoosC Trial Grp

doi:10.1159/000351346

The SafeBoosC Phase II Randomised Clinical Trial: A Treatment Guideline for Targeted Near-Infrared-Derived Cerebral Tissue Oxygenation versus Standard Treatment in Extremely Preterm Infants

Adelina Pellicer^*, Gorm Greisen, Manon Benders, Olivier Claris, Eugene Dempsey, Monica Fumagalli, Christian Gluud, Cornelia Hagmann, Lena Hellstroem-Westas, Simon Hyttel-Sorensen, Petra Lemmers, Gunnar Naulaers, Gerhard Pichler, Claudia Roll, Frank van Bel, Wim van Oeveren, Maria Skoog, Martin Wolf, Topun Austin, SafeBoosC Trial Grp

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

105 Citations (Scopus)

Abstract

Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin (rSto(2)) reflects venous oxygen saturation. If cerebral metabolism is stable, rSto(2) can be used as an estimate of cerebral oxygen delivery. The SafeBoosC phase II randomised clinical trial hypothesises that the burden of hypo- and hyperoxia can be reduced by the combined use of close monitoring of the cerebral rSto(2) and a treatment guideline to correct deviations in rSto(2) outside a predefined target range. Aims: To describe the rationale for and content of this treatment guideline. Methods: Review of the literature and assessment of the quality of evidence and the grade of recommendation for each of the interventions. Results and Conclusions: A clinical intervention algorithm based on the main determinants of cerebral perfusion-oxygenation changes during the first hours after birth was generated. The treatment guideline is presented to assist neonatologists in making decisions in relation to cerebral oximetry readings in preterm infants within the SafeBoosC phase II randomised clinical trial. The evidence grades were relatively low and the guideline cannot be recommended outside a research setting. (C) 2013 S. Karger AG, Basel

Original language	English
Pages (from-to)	171-178
Number of pages	8
Journal	Neonatology
Volume	104
Issue number	3
DOIs	https://doi.org/10.1159/000351346
Publication status	Published - 2013

Keywords

Near-infrared spectroscopy
Newborn
Practice guideline
Cardiovascular agents
Hypotension
Oxygen consumption
Carbon dioxide
Hyperoxia
PATENT DUCTUS-ARTERIOSUS
BIRTH-WEIGHT INFANTS
LEFT-VENTRICULAR OUTPUT
SERVICES-TASK-FORCE
BLOOD-FLOW
PREMATURE-INFANTS
SURGICAL CLOSURE
CARDIAC-OUTPUT
INTENSIVE-CARE
INTRAVENTRICULAR HEMORRHAGE

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Pellicer, A., Greisen, G., Benders, M., Claris, O., Dempsey, E., Fumagalli, M., Gluud, C., Hagmann, C., Hellstroem-Westas, L., Hyttel-Sorensen, S., Lemmers, P., Naulaers, G., Pichler, G., Roll, C., van Bel, F., van Oeveren, W., Skoog, M., Wolf, M., Austin, T., & SafeBoosC Trial Grp (2013). The SafeBoosC Phase II Randomised Clinical Trial: A Treatment Guideline for Targeted Near-Infrared-Derived Cerebral Tissue Oxygenation versus Standard Treatment in Extremely Preterm Infants. Neonatology, 104(3), 171-178. https://doi.org/10.1159/000351346

@article{8935c40b8dfa491e9b78ca1d6bbde0af,

title = "The SafeBoosC Phase II Randomised Clinical Trial: A Treatment Guideline for Targeted Near-Infrared-Derived Cerebral Tissue Oxygenation versus Standard Treatment in Extremely Preterm Infants",

abstract = "Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin (rSto(2)) reflects venous oxygen saturation. If cerebral metabolism is stable, rSto(2) can be used as an estimate of cerebral oxygen delivery. The SafeBoosC phase II randomised clinical trial hypothesises that the burden of hypo- and hyperoxia can be reduced by the combined use of close monitoring of the cerebral rSto(2) and a treatment guideline to correct deviations in rSto(2) outside a predefined target range. Aims: To describe the rationale for and content of this treatment guideline. Methods: Review of the literature and assessment of the quality of evidence and the grade of recommendation for each of the interventions. Results and Conclusions: A clinical intervention algorithm based on the main determinants of cerebral perfusion-oxygenation changes during the first hours after birth was generated. The treatment guideline is presented to assist neonatologists in making decisions in relation to cerebral oximetry readings in preterm infants within the SafeBoosC phase II randomised clinical trial. The evidence grades were relatively low and the guideline cannot be recommended outside a research setting. (C) 2013 S. Karger AG, Basel",

keywords = "Near-infrared spectroscopy, Newborn, Practice guideline, Cardiovascular agents, Hypotension, Oxygen consumption, Carbon dioxide, Hyperoxia, PATENT DUCTUS-ARTERIOSUS, BIRTH-WEIGHT INFANTS, LEFT-VENTRICULAR OUTPUT, SERVICES-TASK-FORCE, BLOOD-FLOW, PREMATURE-INFANTS, SURGICAL CLOSURE, CARDIAC-OUTPUT, INTENSIVE-CARE, INTRAVENTRICULAR HEMORRHAGE",

author = "Adelina Pellicer and Gorm Greisen and Manon Benders and Olivier Claris and Eugene Dempsey and Monica Fumagalli and Christian Gluud and Cornelia Hagmann and Lena Hellstroem-Westas and Simon Hyttel-Sorensen and Petra Lemmers and Gunnar Naulaers and Gerhard Pichler and Claudia Roll and {van Bel}, Frank and {van Oeveren}, Wim and Maria Skoog and Martin Wolf and Topun Austin and {SafeBoosC Trial Grp}",

year = "2013",

doi = "10.1159/000351346",

language = "English",

volume = "104",

pages = "171--178",

journal = "Neonatology",

issn = "1661-7800",

publisher = "KARGER",

number = "3",

}

Pellicer, A, Greisen, G, Benders, M, Claris, O, Dempsey, E, Fumagalli, M, Gluud, C, Hagmann, C, Hellstroem-Westas, L, Hyttel-Sorensen, S, Lemmers, P, Naulaers, G, Pichler, G, Roll, C, van Bel, F, van Oeveren, W, Skoog, M, Wolf, M, Austin, T & SafeBoosC Trial Grp 2013, 'The SafeBoosC Phase II Randomised Clinical Trial: A Treatment Guideline for Targeted Near-Infrared-Derived Cerebral Tissue Oxygenation versus Standard Treatment in Extremely Preterm Infants', Neonatology, vol. 104, no. 3, pp. 171-178. https://doi.org/10.1159/000351346

The SafeBoosC Phase II Randomised Clinical Trial: A Treatment Guideline for Targeted Near-Infrared-Derived Cerebral Tissue Oxygenation versus Standard Treatment in Extremely Preterm Infants. / Pellicer, Adelina; Greisen, Gorm; Benders, Manon et al.
In: Neonatology, Vol. 104, No. 3, 2013, p. 171-178.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - The SafeBoosC Phase II Randomised Clinical Trial

T2 - A Treatment Guideline for Targeted Near-Infrared-Derived Cerebral Tissue Oxygenation versus Standard Treatment in Extremely Preterm Infants

AU - Pellicer, Adelina

AU - Greisen, Gorm

AU - Benders, Manon

AU - Claris, Olivier

AU - Dempsey, Eugene

AU - Fumagalli, Monica

AU - Gluud, Christian

AU - Hagmann, Cornelia

AU - Hellstroem-Westas, Lena

AU - Hyttel-Sorensen, Simon

AU - Lemmers, Petra

AU - Naulaers, Gunnar

AU - Pichler, Gerhard

AU - Roll, Claudia

AU - van Bel, Frank

AU - van Oeveren, Wim

AU - Skoog, Maria

AU - Wolf, Martin

AU - Austin, Topun

AU - SafeBoosC Trial Grp

PY - 2013

Y1 - 2013

N2 - Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin (rSto(2)) reflects venous oxygen saturation. If cerebral metabolism is stable, rSto(2) can be used as an estimate of cerebral oxygen delivery. The SafeBoosC phase II randomised clinical trial hypothesises that the burden of hypo- and hyperoxia can be reduced by the combined use of close monitoring of the cerebral rSto(2) and a treatment guideline to correct deviations in rSto(2) outside a predefined target range. Aims: To describe the rationale for and content of this treatment guideline. Methods: Review of the literature and assessment of the quality of evidence and the grade of recommendation for each of the interventions. Results and Conclusions: A clinical intervention algorithm based on the main determinants of cerebral perfusion-oxygenation changes during the first hours after birth was generated. The treatment guideline is presented to assist neonatologists in making decisions in relation to cerebral oximetry readings in preterm infants within the SafeBoosC phase II randomised clinical trial. The evidence grades were relatively low and the guideline cannot be recommended outside a research setting. (C) 2013 S. Karger AG, Basel

AB - Near-infrared spectroscopy-derived regional tissue oxygen saturation of haemoglobin (rSto(2)) reflects venous oxygen saturation. If cerebral metabolism is stable, rSto(2) can be used as an estimate of cerebral oxygen delivery. The SafeBoosC phase II randomised clinical trial hypothesises that the burden of hypo- and hyperoxia can be reduced by the combined use of close monitoring of the cerebral rSto(2) and a treatment guideline to correct deviations in rSto(2) outside a predefined target range. Aims: To describe the rationale for and content of this treatment guideline. Methods: Review of the literature and assessment of the quality of evidence and the grade of recommendation for each of the interventions. Results and Conclusions: A clinical intervention algorithm based on the main determinants of cerebral perfusion-oxygenation changes during the first hours after birth was generated. The treatment guideline is presented to assist neonatologists in making decisions in relation to cerebral oximetry readings in preterm infants within the SafeBoosC phase II randomised clinical trial. The evidence grades were relatively low and the guideline cannot be recommended outside a research setting. (C) 2013 S. Karger AG, Basel

KW - Near-infrared spectroscopy

KW - Newborn

KW - Practice guideline

KW - Cardiovascular agents

KW - Hypotension

KW - Oxygen consumption

KW - Carbon dioxide

KW - Hyperoxia

KW - PATENT DUCTUS-ARTERIOSUS

KW - BIRTH-WEIGHT INFANTS

KW - LEFT-VENTRICULAR OUTPUT

KW - SERVICES-TASK-FORCE

KW - BLOOD-FLOW

KW - PREMATURE-INFANTS

KW - SURGICAL CLOSURE

KW - CARDIAC-OUTPUT

KW - INTENSIVE-CARE

KW - INTRAVENTRICULAR HEMORRHAGE

U2 - 10.1159/000351346

DO - 10.1159/000351346

M3 - Article

SN - 1661-7800

VL - 104

SP - 171

EP - 178

JO - Neonatology

JF - Neonatology

IS - 3

ER -

The SafeBoosC Phase II Randomised Clinical Trial: A Treatment Guideline for Targeted Near-Infrared-Derived Cerebral Tissue Oxygenation versus Standard Treatment in Extremely Preterm Infants

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Keywords

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