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 .
Clinical use of cerebral oximetry in extremely preterm infants is feasible.
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
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 .