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 .
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
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 ,
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 .