No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC <scp>II</scp>) in preterm infants during the first days of life

Plomgaard, Anne Mette; Alderliesten, Thomas; Bel, Frank van; Benders, Manon; Claris, Olivier; Cordeiro, Malaika; Dempsey, Eugene M.; Fumagalli, Monica; Gluud, Christian; Hyttel-Sørensen, Simon; Lemmers, Petra; Pellicer, Adelina; Pichler, Gerhard; Greisen, Gorm

doi:10.1111/apa.14463

Cited by 52 publications

(48 citation statements)

References 24 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The trial showed significantly better cranial ultrasound severity scores in the treatment group than the control group in early scans and at term equivalent age. However, there was no significant difference in overall cranial ultrasound scores, MRI findings, early electroencephalography, blood biomarkers of brain injury or neurodevelopmental outcomes between their two trial groups 21–23. Our study highlights the possibility that the threshold of 55% is not applicable to all study populations.…”

Section: Discussionmentioning

confidence: 66%

Burden of hypoxia and intraventricular haemorrhage in extremely preterm infants

Costa

Zeiler

et al. 2019

Arch Dis Child Fetal Neonatal Ed

View full text Add to dashboard Cite

ObjectiveThresholds of cerebral hypoxia through monitoring of near-infrared spectroscopy tissue oxygenation index (TOI) were used to investigate the relationship between intraventricular haemorrhage (IVH) and indices of hypoxia.DesignProspective observational study.SettingA single-centre neonatal intensive care unit.PatientsInfants <28 weeks’ gestation with an umbilical artery catheter.MethodsThresholds of hypoxia were determined from mean values of TOI using sequential Χ2 tests and used alongside thresholds from existing literature to calculate percentage of time in hypoxia and burden of hypoxia below each threshold. These indices were then compared between IVH groups.Results44 infants were studied for a median of 18.5 (range 6–21) hours in the first 24 hours of life. Sequential Χ2 analysis yielded a TOI threshold of 71% to differentiate between IVH (16 infants) and no IVH (28 infants). Percentage of time in hypoxia was significantly higher in infants with IVH than those without, using thresholds of 60%–67%. Burden of hypoxia was significantly higher in infants with IVH than without, using thresholds of 62%–80%. With the threshold of 71%, percentage of time in hypoxia was lower by 12.2% with a 95% CI of (−25.7 to 1.2) (p=0.073), and the burden of hypoxia was lower by 29.2% hour (%h) (95% CI −55.2 to −3.1)%h (p=0.012) in infants without IVH than those with IVH.ConclusionsUsing defined TOI thresholds, infants with IVH spent higher percentage of time in hypoxia with higher burden of cerebral hypoxia than those without, in the first 24 hours of life.

show abstract

Section: Discussionmentioning

confidence: 66%

Burden of hypoxia and intraventricular haemorrhage in extremely preterm infants

Costa

Zeiler

et al. 2019

Arch Dis Child Fetal Neonatal Ed

View full text Add to dashboard Cite

show abstract

“…In a 2011 review article, Greisen et al estimated that a trial with sufficient power to detect a 20% reduction of the incidence of brain injury in extreme premature neonates should recruit about 4000 patients . A recent international phase II feasibility randomized clinical trial in 160 extremely preterm infants showed a reduction in cerebral hypoxic events due to a NIRS‐guided treatment protocol but failed to detect any effect on the occurrence of early biomarkers of brain injury or EEG burst rates and neurodevelopmental outcome at 2 years of age . In this neonatal ICU trial, only one intervention to normalize c‐rSO 2 values was allowed at a time and the patient was re‐assessed 30‐60 minutes later.…”

Section: A Practical Introduction To Near‐infrared Spectroscopy (Nirs)mentioning

confidence: 94%

“…60 A recent international phase II feasibility randomized clinical trial in 160 extremely preterm infants showed a reduction in cerebral hypoxic events due to a NIRS-guided treatment protocol 56 but failed to detect any effect on the occurrence of early biomarkers of brain injury or EEG burst rates 61 and neurodevelopmental outcome at 2 years of age. 62 In this neonatal ICU trial, only one intervention to normalize c-rSO 2 values was allowed at a time and the patient was re-assessed 30-60 minutes later. Transient anticipated changes in c-rSO 2 values due to routine interventions (ie, endotracheal tube suctioning) were not listed in the treatment protocol.…”

Section: Nirs and Patient Outcomementioning

confidence: 99%

A practical approach to cerebral near‐infrared spectroscopy (NIRS) directed hemodynamic management in noncardiac pediatric anesthesia

Weber

Scoones

2019

Pediatric Anesthesia

View full text Add to dashboard Cite

Safeguarding cerebral function is of major importance during pediatric anesthesia. Premature, ex‐premature, and full‐term neonates can be vulnerable to physiological changes that occur during anesthesia and surgery. Data from studies performed during pediatric cardiac surgery and in neonatal/pediatric intensive care units have shown the benefits of near‐infrared spectroscopy (NIRS) monitoring of regional cerebral oxygenation (c‐rSO2). However, NIRS monitoring is seldom used during noncardiac pediatric anesthesia. Despite compelling evidence that blood pressure does not reflect end‐organ perfusion, it is still regarded as the most important determinant of cerebral perfusion and the most relevant hemodynamic management target parameter by most (pediatric) anesthetists. The principle of NIRS monitoring is not self‐explanatory and sometimes seems even counterintuitive, which may explain why many anesthesiologists are reserved regarding its use. The first part of this paper is dedicated to a clinical introduction to NIRS monitoring. Despite scientific efforts, it has not yet been possible to define individual lower limit c‐rSO2 values and it is unlikely this will succeed in the near future. Nonetheless, published treatment algorithms usually specify c‐rSO2 values which may be associated with cerebral hypoxia. Our treatment guideline for maintaining sufficient cerebral oxygenation differs fundamentally from all previously published approaches. We define a baseline c‐rSO2 value, registered in the awake child prior to anesthesia induction, as the lowest acceptable limit during anesthesia and surgery. The cerebral rSO2 is the single target parameter, while blood pressure, heart rate, PaCO2, and SaO2 are major parameters that determine the c‐rSO2. Cerebral NIRS monitoring, interpreted together with its continuously available contributing parameters, may help avoid potentially harmful episodes of cerebral desaturation in anesthetized pediatric patients.

show abstract

“…A recent multi‐center clinical trial assessed ability of cerebral oximeters to impact preterm intensive care. The trial demonstrated that informing care with oximetry could reduce the burden of hypoxia but did not see any link between outcome of patients and oximetry (Plomgaard et al., 2019). International efforts to establish optical monitoring techniques in the NICU should be used as an example for the introduction and acceptance of newer techniques (such as those described in Section 3).…”

Section: Neurological Monitoring: Current Statusmentioning

confidence: 99%

Metabolic brain measurements in the newborn: Advances in optical technologies

2020

View full text Add to dashboard Cite

Neonatal monitoring in neonatal intensive care is pushing the technological boundaries of newborn brain monitoring in order to improve patient outcome. There is an urgent need of a cot side, real time monitoring for assessment of brain injury severity and neurodevelopmental outcome, in particular for term newborn infants with hypoxic‐ischemic brain injury. This topical review discusses why brain tissue metabolic monitoring is important in this group of infants and introduces the currently used neuromonitoring techniques for metabolic monitoring in the neonatal intensive care unit (NICU). New optical techniques that can monitor changes in brain metabolism together with brain hemodynamics at the cot side are presented. Early studies from these emerging technologies have demonstrated their potential to deliver continuous information regarding cerebral physiological changes in sick newborn infants in real time. The promises of these new tools as well as their potential limitations are discussed.

show abstract

No neurodevelopmental benefit of cerebral oximetry in the first randomised trial (SafeBoosC II) in preterm infants during the first days of life

Abstract: Cerebral NIRS monitoring was not associated with long-term benefits or harm with regard to neurodevelopmental outcome at two years of corrected age.

Cited by 52 publications

References 24 publications

Burden of hypoxia and intraventricular haemorrhage in extremely preterm infants

Burden of hypoxia and intraventricular haemorrhage in extremely preterm infants

A practical approach to cerebral near‐infrared spectroscopy (NIRS) directed hemodynamic management in noncardiac pediatric anesthesia

Metabolic brain measurements in the newborn: Advances in optical technologies

Contact Info

Product

Resources

About