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