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

2019 ◽  
Author(s):  
Mathias Hansen ◽  
Adelina Pellicer ◽  
Christian Gluud ◽  
Eugene Dempsey ◽  
Jonathan Mintzer ◽  
...  
Keyword(s):  
Infrared Spectroscopy ◽  
Preterm Infants ◽  
Near Infrared ◽  
Control Group ◽  
Severe Brain Injury ◽  
Treatment As Usual ◽  
Opt Out ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Postmenstrual Age

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 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

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

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Mathias Lühr Hansen ◽  
Adelina Pellicer ◽  
Christian Gluud ◽  
Eugene Dempsey ◽  
Jonathan Mintzer ◽  
...  
Keyword(s):  
Infrared Spectroscopy ◽  
Preterm Infants ◽  
Near Infrared ◽  
Control Group ◽  
Severe Brain Injury ◽  
Treatment As Usual ◽  
Opt Out ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Postmenstrual Age

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.

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

2019 ◽  
Author(s):  
Mathias Hansen ◽  
Adelina Pellicer ◽  
Christian Gluud ◽  
Eugene Dempsey ◽  
Jonathan Mintzer ◽  
...  
Keyword(s):  
Preterm Infants ◽  
Cerebral Oxygenation ◽  
Phase Iii ◽  
Control Group ◽  
Treatment As Usual ◽  
Risk Of Death ◽  
Opt Out ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Postmenstrual Age

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 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.

scholarly journals Near-Infrared Spectroscopy in Extremely Preterm Infants

2021 ◽  
Vol 8 ◽  
Author(s):  
Leeann R. Pavlek ◽  
Clifford Mueller ◽  
Maria R. Jebbia ◽  
Matthew J. Kielt ◽  
Omid Fathi
Keyword(s):  
Infrared Spectroscopy ◽  
Preterm Infants ◽  
Near Infrared Spectroscopy ◽  
Neonatal Intensive Care ◽  
Near Infrared ◽  
Tissue Oxygen Saturation ◽  
Tissue Oxygen ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Potential Applications

With advances in neonatal care, survival of premature infants at the limits of viability has improved significantly. Despite these improvement in mortality, infants born at 22–24 weeks gestation are at a very high risk for short- and long-term morbidities associated with prematurity. Many of these diseases have been attributed to abnormalities of tissue oxygenation and perfusion. Near-infrared spectroscopy utilizes the unique absorption properties of oxyhemoglobin and deoxyhemoglobin to provide an assessment of regional tissue oxygen saturation, which can be used to calculate the fractional tissue oxygen extraction. This allows for a non-invasive way to monitor tissue oxygen consumption and enables targeted hemodynamic management. This mini-review provides a brief and complete overview of the background and physiology of near-infrared spectroscopy, practical use in extremely preterm infants, and potential applications in the neonatal intensive care unit. In this mini-review, we aim to summarize the three primary application sites for near-infrared spectroscopy, disease-specific indications, and available literature regarding use in extremely preterm infants.

scholarly journals Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial

BMJ ◽  
2015 ◽  
Vol 350 (jan05 2) ◽  
pp. g7635-g7635 ◽  
Author(s):  
S. Hyttel-Sorensen ◽  
A. Pellicer ◽  
T. Alderliesten ◽  
T. Austin ◽  
F. van Bel ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Infrared Spectroscopy ◽  
Preterm Infants ◽  
Phase Ii ◽  
Near Infrared Spectroscopy ◽  
Near Infrared ◽  
Randomised Clinical Trial ◽  
Extremely Preterm ◽  
Extremely Preterm Infants

Correlations between near-infrared spectroscopy, perfusion index, and cardiac outputs in extremely preterm infants in the first 72 h of life

2018 ◽  
Vol 177 (4) ◽  
pp. 541-550 ◽  
Author(s):  
Marie Janaillac ◽  
Thierry P. Beausoleil ◽  
Keith J. Barrington ◽  
Marie-Josée Raboisson ◽  
Oliver Karam ◽  
...  
Keyword(s):  
Infrared Spectroscopy ◽  
Preterm Infants ◽  
Near Infrared Spectroscopy ◽  
Near Infrared ◽  
Perfusion Index ◽  
Extremely Preterm ◽  
Extremely Preterm Infants

scholarly journals Association of early postnatal transfer and birth outside a tertiary hospital with mortality and severe brain injury in extremely preterm infants: observational cohort study with propensity score matching

BMJ ◽  
2019 ◽  
pp. l5678 ◽  
Author(s):  
Kjell Helenius ◽  
Nicholas Longford ◽  
Liisa Lehtonen ◽  
Neena Modi ◽  
Chris Gale
Keyword(s):  
Brain Injury ◽  
Preterm Infants ◽  
Tertiary Care ◽  
Tertiary Hospital ◽  
Severe Brain Injury ◽  
Extremely Preterm ◽  
Extremely Preterm Infants ◽  
Significant Difference ◽  
Transfer Group ◽  
Upward Transfer

Abstract Objective To determine if postnatal transfer or birth in a non-tertiary hospital is associated with adverse outcomes. Design Observational cohort study with propensity score matching. Setting National health service neonatal care in England; population data held in the National Neonatal Research Database. Participants Extremely preterm infants born at less than 28 gestational weeks between 2008 and 2015 (n=17 577) grouped based on birth hospital and transfer within 48 hours of birth: upward transfer (non-tertiary to tertiary hospital, n=2158), non-tertiary care (born in non-tertiary hospital; not transferred, n=2668), and controls (born in tertiary hospital; not transferred, n=10 866). Infants were matched on propensity scores and predefined background variables to form subgroups with near identical distributions of confounders. Infants transferred between tertiary hospitals (horizontal transfer) were separately matched to controls in a 1:5 ratio. Main outcome measures Death, severe brain injury, and survival without severe brain injury. Results 2181 infants, 727 from each group (upward transfer, non-tertiary care, and control) were well matched. Compared with controls, infants in the upward transfer group had no significant difference in the odds of death before discharge (odds ratio 1.22, 95% confidence interval 0.92 to 1.61) but significantly higher odds of severe brain injury (2.32, 1.78 to 3.06; number needed to treat (NNT) 8) and significantly lower odds of survival without severe brain injury (0.60, 0.47 to 0.76; NNT 9). Compared with controls, infants in the non-tertiary care group had significantly higher odds of death (1.34, 1.02 to 1.77; NNT 20) but no significant difference in the odds of severe brain injury (0.95, 0.70 to 1.30) or survival without severe brain injury (0.82, 0.64 to 1.05). Compared with infants in the upward transfer group, infants in the non-tertiary care group had no significant difference in death before discharge (1.10, 0.84 to 1.44) but significantly lower odds of severe brain injury (0.41, 0.31 to 0.53; NNT 8) and significantly higher odds of survival without severe brain injury (1.37, 1.09 to 1.73; NNT 14). No significant differences were found in outcomes between the horizontal transfer group (n=305) and controls (n=1525). Conclusions In extremely preterm infants, birth in a non-tertiary hospital and transfer within 48 hours are associated with poor outcomes when compared with birth in a tertiary setting. We recommend perinatal services promote pathways that facilitate delivery of extremely preterm infants in tertiary hospitals in preference to postnatal transfer.

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