Cerebral near-infrared spectroscopy monitoring for prevention of brain injury in very preterm infants

Hyttel-Sørensen, Simon; Greisen, Gorm; Als‐Nielsen, Bodil; Gluud, Christian

doi:10.1002/14651858.cd011506.pub2

Cited by 47 publications

(50 citation statements)

References 67 publications

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“…Transcutaneous oxygen and CO 2 monitoring can also be used to access continuous information for trending but can cause skin injury especially in the most immature infants [152]. Methods of monitoring cerebral oxygenation are also available with potential to assess cerebral saturation, but no clear clinical benefit has been identified [153]. Close monitoring of serum electrolytes and haematological values is necessary ideally using micro-sampling techniques.…”

Section: Monitoring and Supportive Carementioning

confidence: 99%

European Consensus Guidelines on the Management of Respiratory Distress Syndrome – 2019 Update

et al. 2019

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As management of respiratory distress syndrome (RDS) advances, clinicians must continually revise their current practice. We report the fourth update of “European Guidelines for the Management of RDS” by a European panel of experienced neonatologists and an expert perinatal obstetrician based on available literature up to the end of 2018. Optimising outcome for babies with RDS includes prediction of risk of preterm delivery, need for appropriate maternal transfer to a perinatal centre and timely use of antenatal steroids. Delivery room management has become more evidence-based, and protocols for lung protection including initiation of CPAP and titration of oxygen should be implemented immediately after birth. Surfactant replacement therapy is a crucial part of management of RDS, and newer protocols for its use recommend early administration and avoidance of mechanical ventilation. Methods of maintaining babies on non-invasive respiratory support have been further developed and may cause less distress and reduce chronic lung disease. As technology for delivering mechanical ventilation improves, the risk of causing lung injury should decrease, although minimising time spent on mechanical ventilation using caffeine and, if necessary, postnatal steroids are also important considerations. Protocols for optimising general care of infants with RDS are also essential with good temperature control, careful fluid and nutritional management, maintenance of perfusion and judicious use of antibiotics all being important determinants of best outcome.

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Section: Monitoring and Supportive Carementioning

confidence: 99%

European Consensus Guidelines on the Management of Respiratory Distress Syndrome – 2019 Update

et al. 2019

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“…A Cochrane Review concluded that it is not possible, based on currently available literature, to determine the specific benefits or harms of NIRS monitoring in extremely preterm infants (27). The conclusion of this review was that NIRS monitoring should only be used in randomized clinical trials (28). Despite this, NIRS is routinely used in extremely preterm infants during the first days of life in numerous NICUs in multiple countries (29).…”

Section: Discussionmentioning

confidence: 99%

Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants. A protocol for the SafeBoosC phase III randomized clinical trial

Hansen

Pellicer

Gluud

et al. 2019

Preprint

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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 randomized, pragmatic phase III clinical trial. It is open label, but parts will be conducted blinded to intervention. Inclusion criteria consists of infants born below 28 weeks postmenstrual age and parental informed consent (unless the site has is using ‘opt-out’ or deferred consent). Exclusion criteria consists of missing parental informed consent (or if ‘opt-out’ is used, lack of record that clinical staff have explained the trial and the ‘opt-out’ consent process to parents and/or a record in the infant’s clinical file of parents’ decision to opt-out); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 hours after birth. Participants will be randomized 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 hours 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. To detect a 22% relative risk difference between the experimental and control group, we intend to randomize a cohort of 1600 infant. Discussion Treatment guided by cerebral NIRS oximetry has the potential to decrease 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.

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“…A Cochrane systematic rReview concluded that it is not possible, based on the currently available literature, to determine the specific benefits or harms of NIRS monitoring in extremely preterm infants (27). The conclusion of this review was that NIRS monitoring should only be used in randomiszed clinical trials (31). Despite this, NIRS is routinely used in extremely preterm infants during the first days of life in numerous NICUs in multiple countries (32).…”

Section: Discussionmentioning

confidence: 99%

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

Hansen

Pellicer

Gluud

et al. 2019

Preprint

Self Cite

View full text Add to dashboard Cite

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 record that clinical staff have explained the trial and the ‘opt-out’ consent process to parents and/or a record of parents’ decision to opt-out in the infants clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 hours 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 hours 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 10/12-2018), https://clinicaltrials.gov/ct2/show/NCT03770741?recrs=b&cond=cerebral+near+infrared+spectroscopy&rank=3

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Cerebral near-infrared spectroscopy monitoring for prevention of brain injury in very preterm infants

Cited by 47 publications

References 67 publications

European Consensus Guidelines on the Management of Respiratory Distress Syndrome – 2019 Update

European Consensus Guidelines on the Management of Respiratory Distress Syndrome – 2019 Update

Cerebral near-infrared spectroscopy monitoring versus treatment as usual for extremely preterm infants. A protocol for the SafeBoosC phase III randomized clinical trial

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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