A phase II randomized clinical trial on cerebral near-infrared spectroscopy plus a treatment guideline versus treatment as usual for extremely preterm infants during the first three days of life (SafeBoosC): study protocol for a randomized controlled trial Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial Cerebral Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates for the Immediate Transition after Birth: A 2-Center Randomized Controlled Pilot Feasibility Trial. Clinical use of cerebral oximetry in extremely preterm infants is feasible. Cerebral tissue oxygenation index and lactate at 24 hours postoperative predict survival and neurodevelopmental outcome after neonatal cardiac surgery Cerebral oxygenation, extraction, and autoregulation in very preterm infants who develop peri-intraventricular hemorrhage. Randomized trial of near-infrared spectroscopy for personalized optimization of cerebral tissue oxygenation during cardiac surgery Do Sustained Lung Inflations during Neonatal Resuscitation Affect Cerebral Blood Volume in Preterm Infants? A Randomized Controlled Pilot Study Intraoperative monitoring of cerebral NIRS oximetry leads to better postoperative cognitive performance: a pilot study. Neurodevelopmental outcomes of premature infants with severe respiratory failure enrolled in a randomized controlled trial of inhaled nitric oxide. The effectiveness of cerebral oxygenation monitoring during arthroscopic shoulder surgery in the beach chair position: a randomized blinded study. Neurodevelopmental outcomes after regional cerebral perfusion with neuromonitoring for neonatal aortic arch reconstruction. Cerebral near infrared spectroscopy: emitter-detector separation must be increased. Measurement of cerebral oxygenation state in anaesthetized children using the INVOS 5100 cerebral oximeter. Alterations in brain structure and neurodevelopmental outcome in preterm infants hospitalized in different neonatal intensive care unit environments. Neurodevelopmental outcomes in the early CPAP and pulse oximetry trial. Developmental intervention for preterm infants diagnosed with periventricular leukomalacia.
Background Every year in Europe about 25,000 infants are born extremely preterm . These infants have a 20 % mortality rate , and 25 % of survivors have severe long-term cerebral impairment . Preventative measures are key to reduce mortality and morbidity in an extremely preterm population . The primary objective of the SafeBoosC phase II trial is to examine if it is possible to stabilize the cerebral oxygenation of extremely preterm infants during the first 72 hours of life through the application of cerebral near-infrared spectroscopy ( NIRS ) oximetry and implementation of an clinical treatment guideline based on intervention thresholds of cerebral regional tissue saturation rStO2 . Methods / Design SafeBoosC is a r and omized , blinded , multinational , phase II clinical trial . The inclusion criteria are : neonates born more than 12 weeks preterm ; decision to conduct full life support ; parental informed consent ; and possibility to place the cerebral NIRS oximeter within 3 hours after birth . The infants will be r and omized into one of two groups . Both groups will have a cerebral oximeter monitoring device placed within three hours of birth . In the experimental group , the cerebral oxygenation reading will supplement the st and ard treatment using a predefined treatment guideline . In the control group , the cerebral oxygenation reading will not be visible and the infant will be treated according to the local st and ards . The primary outcome is the multiplication of the duration and magnitude of rStO2 values outside the target ranges of 55 % to 85 % , that is , the ‘ burden of hypoxia and hyperoxia ’ expressed in ‘ % hours ’ . To detect a 50 % difference between the experimental and control group in % hours , 166 infants in total must be r and omized . Secondary outcomes are mortality at term date , cerebral ultrasound score , and interburst intervals on an amplitude-integrated electroencephalogram at 64 hours of life and explorative outcomes include neurodevelopmental outcome at 2 years corrected age , magnetic resonance imaging at term , blood biomarkers at 6 and 64 hours after birth , and adverse events . Discussion Cerebral oximetry guided interventions have the potential to improve neurodevelopmental outcome in extremely preterm infants . It is a logical first step to test if it is possible to reduce the burden of hypoxia and hyperoxia . Trial registration Clinical Trial.gov , Objective To determine if it is possible to stabilise the cerebral oxygenation of extremely preterm infants monitored by cerebral near infrared spectroscopy ( NIRS ) oximetry . Design Phase II r and omised , single blinded , parallel clinical trial . Setting Eight tertiary neonatal intensive care units in eight European countries . Participants 166 extremely preterm infants born before 28 weeks of gestation : 86 were r and omised to cerebral NIRS monitoring and 80 to blinded NIRS monitoring .  The only exclusion criterion was a decision not to provide life support . Interventions Monitoring of cerebral oxygenation using NIRS in combination with a dedicated treatment guideline during the first 72 hours of life ( experimental ) compared with blinded NIRS oxygenation monitoring with st and ard care ( control ) . Main outcome measures The primary outcome measure was the time spent outside the target range of 55 - 85 % for cerebral oxygenation multiplied by the mean absolute deviation , expressed in % hours ( burden of hypoxia and hyperoxia ) . One hour with an oxygenation of 50 % gives 5%hours of hypoxia . Secondary outcomes were all cause mortality at term equivalent age and a brain injury score assessed by cerebral ultrasonography . R and omisation Allocation sequence 1:1 with block sizes 4 and 6 in r and om order concealed for the investigators . The allocation was stratified for gestational age ( < 26 weeks or ≥26 weeks ) . Blinding Cerebral oxygenation measurements were blinded in the control group . All outcome assessors were blinded to group allocation . Results The 86 infants r and omised to the NIRS group had a median burden of hypoxia and hyperoxia of 36.1%hours ( interquartile range 9.2 - 79.5%hours ) compared with 81.3 ( 38.5 - 181.3 ) % hours in the control group , a reduction of 58 % ( 95 % confidence interval 35 % to 73 % , P<0.001 ) . In the experimental group the median burden of hypoxia was 16.6 ( interquartile range 5.4 - 68.1 ) % hours , compared with 53.6 ( 17.4 - 171.3 ) % hours in the control group ( P=0.0012 ) . The median burden of hyperoxia was similar between the groups : 1.2 ( interquartile range 0.3 - 9.6 ) % hours in the experimental group compared with 1.1 ( 0.1 - 23.4 ) % hours in the control group ( P=0.98 ) . We found no statistically significant differences between the two groups at term corrected age . No severe adverse reactions were associated with the device . Conclusions Cerebral oxygenation was stabilised in extremely preterm infants using a dedicated treatment guideline in combination with cerebral NIRS monitoring . Trial registration Clinical Trial.gov NCT01590316 OBJECTIVE To assess if monitoring of cerebral regional tissue oxygen saturation ( crSO2 ) using near-infrared spectroscopy ( NIRS ) to guide respiratory and supplemental oxygen support reduces burden of cerebral hypoxia and hyperoxia in preterm neonates during resuscitation after birth . STUDY DESIGN Preterm neonates < 34(+0 ) weeks of gestation were included in a prospect i ve r and omized controlled pilot feasibility study at 2 tertiary level neonatal intensive care units . In a NIRS-visible group , crSO2 monitoring in addition to pulse oximetry was used to guide respiratory and supplemental oxygen support during the first 15 minutes after birth . In a NIRS-not-visible group , only pulse oximetry was used . The primary outcomes were burden of cerebral hypoxia ( < 10th percentile ) or hyperoxia ( > 90th percentile ) measured in % minutes crSO2 during the first 15 minutes after birth . Secondary outcomes were all cause of mortality and /or cerebral injury and neurologic outcome at term age . Allocation sequence was 1:1 with block-r and omization of 30 preterm neonates at each site . RESULTS In the NIRS-visible group burden of cerebral hypoxia in % minutes , crSO2 was halved , and the relative reduction was 55.4 % ( 95 % CI 37.6 - 73.2 % ; P = .028 ) . Cerebral hyperoxia was observed in NIRS-visible group in 3 neonates with supplemental oxygen and in NIRS-not-visible group in 2 . Cerebral injury rate and neurologic outcome at term age was similar in both groups . Two neonates died in the NIRS-not-visible group and none in the NIRS-visible group . No severe adverse reactions were observed . CONCLUSIONS Reduction of burden of cerebral hypoxia during immediate transition and resuscitation after birth is feasible by crSO2 monitoring to guide respiratory and supplemental oxygen support . TRIAL REGISTRATION Clinical Trials.gov : NCT02017691 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 r and omised to visible cerebral NIRS oximetry with pre-specified treatment guidelines compared to st and ard 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 result ed 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 Clinical trials.gov : NCT01530360 IMPORTANCE There are no well-established noninvasive biomarkers for identifying patients at risk for poor outcome after surgery for congenital heart disease . Few studies have assessed prognostic accuracy of cerebral tissue oxygenation index ( cTOI ) measured by near infrared spectroscopy ( NIRS ) . OBJECTIVE To assess the utility of noninvasive NIRS monitoring as a predictor of outcomes after neonatal cardiac surgery through measurement of cTOI . To examine the utility of noninvasive NIRS monitoring in combination with lactate concentration and inotropic score in prediction of outcomes after neonatal cardiac surgery . DESIGN Prospect i ve longitudinal cohort study . SETTING Operating room and cardiac intensive care unit , Children 's National Heart Institute . PARTICIPANTS Seventy-five patients with complex congenital heart disease undergoing surgical repair within first month of life .  EXPOSURE Cerebral TOI , blood lactate , and inotropic scores were measured preoperative , intraoperative and up to 24 hours postoperative . MAIN OUTCOME MEASURES Postoperative mortality and neurodevelopmental outcome assessed by the Bayley Scales of Infant Development ( BSID II ) . Mental and motor scores were obtained at 6 , 15 , and 21 months . Good outcome was defined as survival and BSID mental and motor scores ≥70 points . Poor outcome was defined as death or BSID scores < 70 at most recent follow-up . RESULTS Cohort of 75 patients prospect ively followed including 40 patients with single ventricle and 35 with two ventricles . Four patients died before discharge and ten died within 21 months . Seven patients were lost to follow-up . Among survivors with follow-up ( n = 54 ) , BSID was abnormal in 25 ( 46 % ) . Patients with poor outcome ( n = 39 ) had lower mean cTOI 60 minutes off-CPB ( 48 % vs. 58 % , P = .003 ) and 24 hours postoperative ( 49 % vs. 59 % , P < .001 ) , higher lactate ( 8.2 vs. 5.0 mmol/L , P = .005 ) and higher inotropic scores ( 10 vs. 6 , P = .02 ) at 24 hours postoperative . ROC analysis indicated that cTOI had moderate predictive accuracy of outcome ( AUC = 0.751 , P < .001 ) . Multivariable regression analysis confirmed that predictive accuracy was improved using both cTOI and lactate at 24 hours postoperative ( AUC = 0.813 , 95 % CI : 0.705 - 0.921 , P < .001 ) with optimal cutoff values < 58 % and > 7.4 mmol/L , respectively ( sensitivity = 95 % ) . CONCLUSION Cerebral TOI combined with lactate at 24 hours postoperative are accurate non-invasive predictive biomarkers of patient survival and neurodevelopmental outcome in neonates with CHD undergoing cardiac surgery OBJECTIVE To test the hypothesis that near-infrared spectroscopy (NIRS)-determined patterns of regional cerebral oxygen saturation ( rScO2 ) , cerebral fractional tissue oxygen extraction ( cFTOE ) , and autoregulatory ability can identify neonates at risk for developing peri-intraventricular hemorrhage ( PIVH ) . STUDY DESIGN This case-control study is a sub analysis of 30 neonates who developed PIVH > 12 hours after admission as part of a lager prospect i ve observational cohort study comprising 650 preterm neonates born at ≤32 weeks ' gestational age . PIVH was diagnosed by cranial ultrasound , performed at least once daily . Mean arterial blood pressure ( MABP ) , NIRS-determined rScO2 , cFTOE , and MABP-rScO2 correlation were monitored from birth to 72 hours of age . RESULTS Infants with PIVH received more inotropic drugs before being diagnosed with PIVH . Significantly more infants with severe PIVH needed treatment for patent ductus arteriosus . The MABP-rScO2 correlation was > 0.5 significantly more often before mild/moderate PIVH and after severe PIVH compared with controls . rScO2 was higher and cFTOE lower in infants before severe PIVH . CONCLUSION NIRS-monitored rScO2 and cFTOE suggest cerebral hyperperfusion in infants with severe PIVH . Moreover , MABP-rScO2 correlation indicates more blood pressure-passive brain perfusion in infants with PIVH . Continuous assessment of patterns of cerebral oxygenation and arterial blood pressure may identify those preterm infants at risk for severe PIVH and prompt consideration of preventive measures Background We assessed whether a near-infrared spectroscopy (NIRS)-based algorithm for the personalized optimization of cerebral oxygenation during cardiopulmonary bypass combined with a restrictive red cell transfusion threshold would reduce perioperative injury to the brain , heart , and kidneys . Methods In a r and omized controlled trial , participants in three UK centres were r and omized with concealed allocation to a NIRS ( INVOS 5100 ; Medtronic Inc. , Minneapolis , MN , USA)-based ' patient-specific ' algorithm that included a restrictive red cell transfusion threshold ( haematocrit 18 % ) or to a ' generic ' non-NIRS-based algorithm ( st and ard care ) . The NIRS algorithm aim ed to maintain cerebral oxygenation at an absolute value of > 50 % or at > 70 % of baseline values . The primary outcome for the trial was cognitive function measured up to 3 months postsurgery . Results The analysis population comprised eligible r and omized patients who underwent valve or combined valve surgery and coronary artery bypass grafts using cardiopulmonary bypass between December 2009 and January 2014 ( n = 98 patient-specific algorithm ; n = 106 generic algorithm ) . There was no difference between the groups for the three core cognitive domains ( attention , verbal memory , and motor coordination ) or for the non-core domains psychomotor speed and visuo-spatial skills . The NIRS group had higher scores for verbal fluency ; mean difference 3.73 ( 95 % confidence interval 1.50 , 5.96 ) . Red cell transfusions , biomarkers of brain , kidney , and myocardial injury , adverse events , and health-care costs were similar between the groups . Conclusions These results do not support the use of NIRS-based algorithms for the personalized optimization of cerebral oxygenation in adult cardiac surgery . Clinical trial registration http://www.controlled-trials.com , IS RCT N 23557269 Background Sustained lung inflations ( SLI ) during neonatal resuscitation may promote alveolar recruitment in preterm infants . While most of the studies focus on respiratory outcome , the impact of SLI on the brain has n’t been investigated yet . Objective Do SLI affect cerebral blood volume ( CBV ) in preterm infants ? Methods Preterm infants of gestation 28 weeks 0 days to 33 weeks 6 days with requirement for respiratory support ( RS ) were included in this r and omized controlled pilot trial . Within the first 15 minutes after birth near-infrared spectroscopy ( NIRS ) measurements using ‘ NIRO-200-NX ’ ( Hamamatsu , Japan ) were performed to evaluate changes in CBV and cerebral tissue oxygenation . Two groups were compared based on RS : In SLI group RS was given by applying 1–3 SLI ( 30 cmH2O for 15 s ) continued by respiratory st and ard care . Control group received respiratory st and ard care only . Results 40 infants ( 20 in each group ) with mean gestational age of 32 weeks one day ( ±2 days ) and birth weight of 1707 ( ±470 ) g were included . In the control group ΔCBV was significantly decreasing , whereas in SLI group ΔCBV showed similar values during the whole period of 15 minutes . Comparing both groups within the first 15 minutes ΔCBV showed a tendency toward different overall courses ( p = 0.051 ) . Conclusion This is the first study demonstrating an impact of SLI on CBV . Further studies are warranted including reconfirmation of the present findings in infants with lower gestational age . Future investigations on SLI should not only focus on respiratory outcome but also on the consequences on the developing brain . Trial Registration German Clinical Trials Register DRKS00005161 OBJECTIVES The aim of this study is the assessment of the regional cerebral oximetry - NIRS ( near infrared spectroscopy ) as an intraoperative monitoring system to protect the patient against the incidents of brain desaturations . We hypothesize that patients monitored with NIRS present a smaller range of postoperative cognitive dysfunctions ( POCD ) in comparison with those without NIRS monitoring during lumbar spine surgery in a prone position . SETTING S This study was performed at the Clinical Department of Neurosurgery and Oncology of the Central Nervous System , Medical University of Lodz , Pol and . PARTICIPANTS The study completed 43 adult patients qualified for the surgical treatment of lumbar spondylosis . Before the procedures they were r and omized into two subgroups : one monitored intraoperatively by means of NIRS cerebral oximetry ( INVOS 5100 ) , which numbered 13 patients – 30.2 % ( 13 NIRS devices were made available to the authors ) and the other without NIRS intraoperative monitoring , totaling 30 people – 69.8 % . The patients who presented a history of psychiatric , neurological and cardiovascular disorders which impair cognitive processes were disqualified from the study . PRIMARY AND SECONDARY OUTCOME MEASURES A comprehensive battery of neuropsychological tests was preoperatively performed on all patients . The subjects were then divided into two groups : with and without NIRS monitoring . Both groups were statistically homogeneous . Computerized anesthesia records were used to obtain intraoperative data : mean arterial pressure , heart rate , pulsoximetry and cerebral regional oxygenation . The depth of anesthesia monitor was not used . Besides , all the patients passed the same battery of neurocognitive tests 7 days and 1 month postoperatively . The Mann-Whitney test was performed to compare POCD and therefore assess the usefulness of NIRS as a monitoring mechanism during anesthesia in the prone position . RESULTS There was a significant ( p < 0.05 ) difference in the presence of cognitive deficiencies between the subgroup monitored with NIRS and the subgroup without NIRS . It included : Digit Span Test overall score and forward repetition score 7 days after operation , N- back Test results after 30 days in version 0 " back " - time , N-back Test version 1 " back " results in the number of correct answers and the number of errors . CONCLUSIONS NIRS cerebral oximetry may be useful in reducing postoperative cognitive complications in patients operated on in the prone positioning . TRIAL REGISTRATION RNN/556/08/KB – approval of the ethics committee at Medical University of Lodz , Pol and OBJECTIVES We hypothesized that inhaled nitric oxide ( iNO ) would not decrease death or neurodevelopmental impairment ( NDI ) in infants enrolled in the National Institute of Child Health and Human Development Preemie iNO Trial ( PiNO ) trial , nor improve neurodevelopmental outcomes in the follow-up group . STUDY DESIGN Infants < 34 weeks of age , weighing < 1500 g , with severe respiratory failure were enrolled in the multicenter , r and omized , controlled trial . NDI at 18 to 22 months corrected age was defined as : moderate to severe cerebral palsy ( CP ; Mental Developmental Index or Psychomotor score Developmental Index < 70 ) , blindness , or deafness . RESULTS Of 420 patients enrolled , 109 who received iNO  ( 52 % ) and 98 who received placebo  ( 47 % ) died . The follow-up rate in survivors was 90 % . iNO did not reduce death or NDI ( 78 % versus 73 % ; relative risk [ RR ] , 1.07 ; 95 % CI , 0.95 - 1.19 ) , or NDI or Mental Developmental Index < 70 in the follow-up group . Moderate-severe CP was slightly higher with iNO ( RR , 2.41 ; 95 % CI , 1.01 - 5.75 ) , as was death or CP in infants weighing < 1000 g ( RR , 1.22 ; 95 % CI , 1.05 - 1.43 ) . CONCLUSIONS In this extremely ill cohort , iNO did not reduce death or NDI or improve neurodevelopmental outcomes .  Routine iNO use in premature infants should be limited to research setting s until further data are available BACKGROUND Beach chair positioning for shoulder surgery is associated with measurable cerebral desaturation events ( CDEs ) in up to 80 % of patients .  Near-infrared spectroscopy ( NIRS ) technology allows real-time measurement of cerebral oxygenation and may minimize the frequency of CDEs . The purpose of this study was to investigate the incidence of CDEs when anesthetists were aware of and blinded to NIRS monitoring and to determine the short-term cognitive effects of surgery in the beach chair position . METHODS NIRS was used to monitor cerebral oxygenation saturation in 41 consecutive patients undergoing arthroscopic shoulder surgery in the beach chair position . Patients were r and omized to 2 groups , anesthetists aware of or blinded to NIRS data . The Montreal Cognitive Assessment ( MoCA ) was used to assess cognitive function preoperatively , immediately postoperatively , and at 2 and 6 weeks postoperatively . RESULTS Overall , 7 ( 17.5 % ) patients experienced a CDE , 5 ( 25 % ) in the aware group and 2 ( 10 % ) in the blinded group . There was no significant difference in MoCA scores between the aware and blinded groups preoperatively ( 27.9.1 vs. 28.2 ; P = .436 ) , immediately postoperatively ( 26.1 vs. 26.2 ; P = .778 ) , 2 weeks postoperatively ( 28.0 vs. 28.1 ; P = .737 ) , or 6 weeks postoperatively ( 28.5 vs. 28.4 ; P = .779 ) . There was a correlation of NIRS with systolic blood pressure ( r = 0.448 ) , diastolic blood pressure ( r = 0.708 ) , and mean arterial pressure ( r = 0.608 ) . CONCLUSION In our series , the incidence of CDEs was much lower than previously reported and was not lowered by use of NIRS . Patients did not have significant cognitive deficits after arthroscopic surgery in the beach chair position , and there was a correlation between NIRS and intraoperative brachial blood pressure BACKGROUND In this study we report magnetic resonance imaging ( MRI ) brain injury and 12-month neurodevelopmental outcomes when regional cerebral perfusion ( RCP ) is used for neonatal aortic arch reconstruction . METHODS Fifty-seven neonates receiving RCP during aortic arch reconstruction were enrolled in a prospect i ve outcome study . RCP flows were determined by near-infrared spectroscopy and transcranial Doppler monitoring . Brain MRI was performed preoperatively and 7 days postoperatively . Bayley Scales of Infant Development III was performed at 12 months . RESULTS Mean RCP time was 71 ± 28 minutes ( range , 5 to 121 minutes ) and mean flow was 56.6 ± 10.6 mL/kg/min . New postoperative MRI brain injury was seen in 40 % of patients . For 35 RCP patients at age 12 months , mean Bayley Scales III Composite st and ard scores were : Cognitive , 100.1 ± 14.6 ( range , 75 to 125 ) ; Language , 87.2 ± 15.0 ( range , 62 to 132 ) ; and Motor , 87.9 ± 16.8 ( range , 58 to 121 ) . Increasing duration of RCP was not associated with adverse neurodevelopmental outcomes . CONCLUSIONS Neonatal aortic arch repair with RCP using a neuromonitoring strategy results in 12-month cognitive outcomes that are at reference population norms . Language and motor outcomes are lower than the reference population norms by 0.8 to 0.9 st and ard deviations . The neurodevelopmental outcomes in this RCP cohort demonstrate that this technique is effective and safe in supporting the brain during neonatal aortic arch reconstruction We have compared the effect of increasing optode separation ( range 0.7 - 5.5 cm ) on the sensitivity of near infrared spectroscopy ( NIRS ) to discrete reductions in scalp and cerebral oxygenation in 10 healthy men ( mean age 32 , range 26 - 39 yr ) using multichannel NIRS . During cerebral oligaemia ( a mean reduction in middle cerebral artery flow velocity of 47 % ) induced by a mean reduction in end-tidal PCO2 of 2.4 kPa , the decrease in oxyhaemoglobin detected by NIRS became significantly greater with increasing optode separation ( P < 0.0001 ) . In response to scalp hyperaemia induced by inflation and release of a pneumatic scalp tourniquet , increases in oxyhaemoglobin became significantly smaller with increasing optode separation ( P < 0.0002 ) . These results are consistent with theoretical models of the behaviour of NIR light in the adult head and support the concept of using multi-detector NIRS to separate intra- and extracranial NIR signal changes . However , the emitter-detector separation used by currently available cerebral oximeters is not large enough to provide optimal spatial resolution BACKGROUND Near-infrared spectroscopy is a developing technique for monitoring cerebral oxygenation during anaesthesia . The aim of this study was to evaluate absolute values of cerebral oxygenation during stable anaesthesia conditions in otherwise healthy children using the recently introduced INVOS 5100 cerebral oximeter with a paediatric and adult sensor and to compare them with values obtained from the NIRO 300 oximeter . METHODS Thirty paediatric surgical patients ( aged 0.23 - 15.97 years ) were studied during general anaesthesia with tracheal intubation and controlled ventilation .  Comparative measurements of cerebral oxygenation were performed on the forehead with two probes within 10 min under stable cardiorespiratory and anaesthesia conditions . Cerebral oxygenation values ( rSO2 ) obtained from the paediatric and adult INVOS 5100 sensors were compared with the tissue oxygenation index ( TOI ) obtained from the NIRO 300 cerebral oximeter using 4- and 5-cm emitter-detector separation . RESULTS Cerebral rSO2 values and the TOI values both showed a large range of cerebral oxygenation in the children studied ( rSO2 : 59 - 95 % , TOI : 48 - 85 % ) . Cerebral rSO2 values measured by the INVOS 5100 , particularly with the paediatric sensor , were significantly higher than the TOI values obtained from the NIRO 300 ( P < 0.0001 ) . Agreement between the INVOS and NIRO oximeter was poor . CONCLUSION The large range and the poor agreement of cerebral oxygenation values between the two oximeters makes it difficult to define a normal value . Cerebral oxygenation readings by these monitors , based on one single point measurement during anaesthesia , should be viewed with caution . Actually , there may be little indication for routine use of such monitoring during general anaesthesia OBJECTIVE To evaluate associations between neonatal intensive care unit ( NICU ) room type ( open ward and private room ) and medical outcomes ; neurobehavior , electrophysiology , and brain structure at hospital discharge ; and developmental outcomes at 2 years of age . STUDY DESIGN In this prospect i ve longitudinal cohort study , we enrolled 136 preterm infants born < 30 weeks gestation from an urban , 75-bed level III NICU from 2007 - 2010 . Upon admission , each participant was assigned to a bedspace in an open ward or private room within the same hospital , based on space and staffing availability , where they remained for the duration of hospitalization . The primary outcome was developmental performance at 2 years of age ( n = 86 infants returned for testing , which was 83 % of survivors ) measured using the Bayley Scales of Infant and Toddler Development , 3rd Edition . Secondary outcomes were : ( 1 ) medical factors throughout the hospitalization ; ( 2 ) neurobehavior ; and ( 3 ) cerebral injury and maturation ( determined by magnetic resonance imaging and electroencephalography ) . RESULTS At term equivalent age , infants in private rooms were characterized by a diminution of normal hemispheric asymmetry and a trend toward having lower amplitude integrated electroencephalography cerebral maturation scores ( P = .02 ; β = -0.52 [ CI -0.95 , -0.10 ] ) . At age 2 years , infants from private rooms had lower language scores ( P = .006 ; β = -8.3 [ CI -14.2 , -2.4 ] ) and a trend toward lower motor scores ( P = .02 ; β = -6.3 [ CI -11.7 , -0.99 ] ) , which persisted after adjustment for potential confounders . CONCLUSION These findings raise concerns that highlight the need for further research into the potential adverse effects of different amounts of sensory exposure in the NICU environment BACKGROUND Previous results from our trial of early treatment with continuous positive airway pressure ( CPAP ) versus early surfactant treatment in infants showed no significant difference in the outcome of death or bronchopulmonary dysplasia . A lower ( vs. higher ) target range of oxygen saturation was associated with a lower rate of severe retinopathy but higher mortality . We now report longer-term results from our prespecified hypotheses . METHODS Using a 2-by-2 factorial design , we r and omly assigned infants born between 24 weeks 0 days and 27 weeks 6 days of gestation to early CPAP with a limited ventilation strategy or early surfactant administration and to lower or higher target ranges of oxygen saturation ( 85 to 89 % or 91 to 95 % ) . The primary composite outcome for the longer-term analysis was death before assessment at 18 to 22 months or neurodevelopmental impairment at 18 to 22 months of corrected age . RESULTS The primary outcome was determined for 1234 of 1316 enrolled infants ( 93.8 % ) ; 990 of the 1058 surviving infants ( 93.6 % ) were evaluated at 18 to 22 months of corrected age . Death or neurodevelopmental impairment occurred in 27.9 % of the infants in the CPAP group ( 173 of 621 infants ) , versus 29.9 % of those in the surfactant group ( 183 of 613 ) ( relative risk , 0.93 ; 95 % confidence interval [ CI ] , 0.78 to 1.10 ; P=0.38 ) , and in 30.2 % of the infants in the lower-oxygen-saturation group ( 185 of 612 ) , versus 27.5 % of those in the higher-oxygen-saturation group ( 171 of 622 ) ( relative risk , 1.12 ; 95 % CI , 0.94 to 1.32 ; P=0.21 ) . Mortality was increased with the lower-oxygen-saturation target ( 22.1 % , vs. 18.2 % with the higher-oxygen-saturation target ; relative risk , 1.25 ; 95 % CI , 1.00 to 1.55 ; P=0.046 ) . CONCLUSIONS We found no significant differences in the composite outcome of death or neurodevelopmental impairment  among extremely premature infants r and omly assigned to early CPAP or early surfactant administration and to a lower or higher target range of oxygen saturation . ( Funded by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Heart , Lung , and Blood Institute ; SUPPORT Clinical Trials.gov number , NCT00233324 . ) Preterm infants with periventricular leukomalacia ( PVL ) were evaluated to determine whether multi-sensory stimulation is safe and to assess whether it improved neurobehavior and neurodevelopment .  Thirty preterm infants with documented PVL were r and omly assigned to control ( n= 15 ) or experimental ( Group E ) ( n= 15 ) groups at 33 weeks post-conceptional age . Group E infants received 15 minutes of auditory , tactile , visual , and vestibular ( ATVV ) intervention twice a day , five days a week , for four weeks during hospitalization . Repeated measures ANOVA demonstrated that Group E infants experienced significant increases in heart and respiratory rate and a 0.72 % drop in hemoglobin saturation , coinciding with a significant behavioral state shift from sleep to alertness during intervention . No differences were identified in neurobehavioral function and neurodevelopment , indicating that Group E suffered no injury . Group E had an average hospital stay nine days shorter than that of controls , with the associated cost savings of $ 213,840 . The earlier hospital discharge indicates that ATVV intervention promotes alertness without compromising physiologic status in vulnerable infants
The only eligible r and omised clinical trial did not demonstrate any consistent effects of NIRS plus a guideline on the assessed clinical outcomes .
The trial was , however , only powered to detect difference in cerebral oxygenation , not morbidities or mortality .
BACKGROUND Cerebral injury and long-term neurodevelopmental impairment is common in extremely preterm infants .
Cerebral near-infrared spectroscopy ( NIRS ) enables continuous estimation of cerebral oxygenation .
This diagnostic method coupled with appropriate interventions if NIRS is out of normal range ( that is cerebral oxygenation within the 55 % to 85 % range ) may offer benefits without causing more harms .
Therefore , NIRS coupled with appropriate responses to abnormal findings on NIRS needs assessment in a systematic review of r and omised clinical trials and quasi-r and omised studies .
OBJECTIVES To evaluate the benefits and harms of interventions that attempt to alter cerebral oxygenation guided by cerebral NIRS monitoring in order to prevent cerebral injury , improve neurological outcome , and increase survival in preterm infants born more than 8 weeks preterm .