Clinical use of cerebral oximetry in extremely preterm infants is feasible

Simon Hyttel-Sørensen, Topun Austin, Frank van Bel, Manon Benders, Olivier Claris, Eugene M. Dempsey, Monica Fumagalli, Christian Gluud, Cornelia Hagmann, Lena Hellström-Westas, Petra Lemmers, Gunnar Naulaers, Wim van Oeveren, Adelina Pellicer, Gerhard Pichler, Claudia Roll, Lina Saem Støy, Martin Wolf, Gorm Greisen

Research output: Contribution to journalArticle

Abstract

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. 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. 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). This study was a pilot of the Visible Oximetry Group. MATERIAL AND METHODS: This was an observational study including ten infants. RESULTS: The median gestational age was 26 weeks + three days, and the median start-up time was 133 minutes after delivery. 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). Clinical staff responded to an out of range value 29 times - only once to values above 85%. In comparison, there were 83 periods of more than ten minutes with an rStO2 below 55% and four episodes with an rStO2 above 85%. These periods accounted for 72% of the total hypoxia burden. 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. Two infants suffered second-degree burns from the sensor. Five infants died. In all cases, this was unrelated to NIRS monitoring and treatment. CONCLUSION: The intervention of early cerebral NIRS monitoring proved feasible, but prolonged periods of hypoxia went untreated. Thus, a revision of the treatment guideline and an alarm system is required. FUNDING: The Elsass Foundation funded the present study. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01530360.

Original languageEnglish
JournalDanish Medical Journal
Volume60
Issue number1
Publication statusPublished - 2013

Fingerprint

Extremely Premature Infants
Oximetry
Near-Infrared Spectroscopy
Guidelines
Burns
Gestational Age
Observational Studies
Reference Values
Hemoglobins
Therapeutics
Oxygen
Pregnancy
Brain
Research
Hypoxia

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Hyttel-Sørensen, S., Austin, T., van Bel, F., Benders, M., Claris, O., Dempsey, E. M., ... Greisen, G. (2013). Clinical use of cerebral oximetry in extremely preterm infants is feasible. Danish Medical Journal, 60(1).

Clinical use of cerebral oximetry in extremely preterm infants is feasible. / Hyttel-Sørensen, Simon; Austin, Topun; van Bel, Frank; Benders, Manon; Claris, Olivier; Dempsey, Eugene M.; Fumagalli, Monica; Gluud, Christian; Hagmann, Cornelia; Hellström-Westas, Lena; Lemmers, Petra; Naulaers, Gunnar; van Oeveren, Wim; Pellicer, Adelina; Pichler, Gerhard; Roll, Claudia; Støy, Lina Saem; Wolf, Martin; Greisen, Gorm.

In: Danish Medical Journal, Vol. 60, No. 1, 2013.

Research output: Contribution to journalArticle

Hyttel-Sørensen, S, Austin, T, van Bel, F, Benders, M, Claris, O, Dempsey, EM, Fumagalli, M, Gluud, C, Hagmann, C, Hellström-Westas, L, Lemmers, P, Naulaers, G, van Oeveren, W, Pellicer, A, Pichler, G, Roll, C, Støy, LS, Wolf, M & Greisen, G 2013, 'Clinical use of cerebral oximetry in extremely preterm infants is feasible', Danish Medical Journal, vol. 60, no. 1.
Hyttel-Sørensen S, Austin T, van Bel F, Benders M, Claris O, Dempsey EM et al. Clinical use of cerebral oximetry in extremely preterm infants is feasible. Danish Medical Journal. 2013;60(1).
Hyttel-Sørensen, Simon ; Austin, Topun ; van Bel, Frank ; Benders, Manon ; Claris, Olivier ; Dempsey, Eugene M. ; Fumagalli, Monica ; Gluud, Christian ; Hagmann, Cornelia ; Hellström-Westas, Lena ; Lemmers, Petra ; Naulaers, Gunnar ; van Oeveren, Wim ; Pellicer, Adelina ; Pichler, Gerhard ; Roll, Claudia ; Støy, Lina Saem ; Wolf, Martin ; Greisen, Gorm. / Clinical use of cerebral oximetry in extremely preterm infants is feasible. In: Danish Medical Journal. 2013 ; Vol. 60, No. 1.
@article{25efebf53c65403485f561b9ac49c2c9,
title = "Clinical use of cerebral oximetry in extremely preterm infants is feasible",
abstract = "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. 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. 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). This study was a pilot of the Visible Oximetry Group. MATERIAL AND METHODS: This was an observational study including ten infants. RESULTS: The median gestational age was 26 weeks + three days, and the median start-up time was 133 minutes after delivery. 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). Clinical staff responded to an out of range value 29 times - only once to values above 85{\%}. In comparison, there were 83 periods of more than ten minutes with an rStO2 below 55{\%} and four episodes with an rStO2 above 85{\%}. These periods accounted for 72{\%} of the total hypoxia burden. 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. Two infants suffered second-degree burns from the sensor. Five infants died. In all cases, this was unrelated to NIRS monitoring and treatment. CONCLUSION: The intervention of early cerebral NIRS monitoring proved feasible, but prolonged periods of hypoxia went untreated. Thus, a revision of the treatment guideline and an alarm system is required. FUNDING: The Elsass Foundation funded the present study. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01530360.",
author = "Simon Hyttel-S{\o}rensen and Topun Austin and {van Bel}, Frank and Manon Benders and Olivier Claris and Dempsey, {Eugene M.} and Monica Fumagalli and Christian Gluud and Cornelia Hagmann and Lena Hellstr{\"o}m-Westas and Petra Lemmers and Gunnar Naulaers and {van Oeveren}, Wim and Adelina Pellicer and Gerhard Pichler and Claudia Roll and St{\o}y, {Lina Saem} and Martin Wolf and Gorm Greisen",
year = "2013",
language = "English",
volume = "60",
journal = "Danish Medical Journal",
issn = "2245-1919",
publisher = "Almindelige Danske Laegeforening",
number = "1",

}

TY - JOUR

T1 - Clinical use of cerebral oximetry in extremely preterm infants is feasible

AU - Hyttel-Sørensen, Simon

AU - Austin, Topun

AU - van Bel, Frank

AU - Benders, Manon

AU - Claris, Olivier

AU - Dempsey, Eugene M.

AU - Fumagalli, Monica

AU - Gluud, Christian

AU - Hagmann, Cornelia

AU - Hellström-Westas, Lena

AU - Lemmers, Petra

AU - Naulaers, Gunnar

AU - van Oeveren, Wim

AU - Pellicer, Adelina

AU - Pichler, Gerhard

AU - Roll, Claudia

AU - Støy, Lina Saem

AU - Wolf, Martin

AU - Greisen, Gorm

PY - 2013

Y1 - 2013

N2 - 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. 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. 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). This study was a pilot of the Visible Oximetry Group. MATERIAL AND METHODS: This was an observational study including ten infants. RESULTS: The median gestational age was 26 weeks + three days, and the median start-up time was 133 minutes after delivery. 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). Clinical staff responded to an out of range value 29 times - only once to values above 85%. In comparison, there were 83 periods of more than ten minutes with an rStO2 below 55% and four episodes with an rStO2 above 85%. These periods accounted for 72% of the total hypoxia burden. 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. Two infants suffered second-degree burns from the sensor. Five infants died. In all cases, this was unrelated to NIRS monitoring and treatment. CONCLUSION: The intervention of early cerebral NIRS monitoring proved feasible, but prolonged periods of hypoxia went untreated. Thus, a revision of the treatment guideline and an alarm system is required. FUNDING: The Elsass Foundation funded the present study. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01530360.

AB - 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. 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. 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). This study was a pilot of the Visible Oximetry Group. MATERIAL AND METHODS: This was an observational study including ten infants. RESULTS: The median gestational age was 26 weeks + three days, and the median start-up time was 133 minutes after delivery. 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). Clinical staff responded to an out of range value 29 times - only once to values above 85%. In comparison, there were 83 periods of more than ten minutes with an rStO2 below 55% and four episodes with an rStO2 above 85%. These periods accounted for 72% of the total hypoxia burden. 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. Two infants suffered second-degree burns from the sensor. Five infants died. In all cases, this was unrelated to NIRS monitoring and treatment. CONCLUSION: The intervention of early cerebral NIRS monitoring proved feasible, but prolonged periods of hypoxia went untreated. Thus, a revision of the treatment guideline and an alarm system is required. FUNDING: The Elsass Foundation funded the present study. TRIAL REGISTRATION: Clinicaltrials.gov: NCT01530360.

UR - http://www.scopus.com/inward/record.url?scp=84873248511&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84873248511&partnerID=8YFLogxK

M3 - Article

AN - SCOPUS:84873248511

VL - 60

JO - Danish Medical Journal

JF - Danish Medical Journal

SN - 2245-1919

IS - 1

ER -