title: Cerebral Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates for the Immediate Transition after Birth: A 2-Center Randomized Controlled Pilot Feasibility Trial.
abstract: 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.
  
  
  METHODS
  Preterm neonates <34(+0) weeks of gestation were included in a prospective randomized 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-randomization 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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02017691.
authors.affiliation: Research Unit for Neonatal Micro- and Macrocirculation, Department of Pediatrics, Medical University of Graz, Graz, Austria; Division of Neonatology, Department of Pediatrics, Medical University of Graz, Graz, Austria.
authors.forename: Gerhard
authors.initials: G
authors.lastname: Pichler
authors.affiliation: Research Unit for Neonatal Micro- and Macrocirculation, Department of Pediatrics, Medical University of Graz, Graz, Austria; Division of Neonatology, Department of Pediatrics, Medical University of Graz, Graz, Austria.
authors.forename: Berndt
authors.initials: B
authors.lastname: Urlesberger
authors.affiliation: Research Unit for Neonatal Micro- and Macrocirculation, Department of Pediatrics, Medical University of Graz, Graz, Austria; Division of Neonatology, Department of Pediatrics, Medical University of Graz, Graz, Austria.
authors.forename: Nariae
authors.initials: N
authors.lastname: Baik
authors.affiliation: Research Unit for Neonatal Micro- and Macrocirculation, Department of Pediatrics, Medical University of Graz, Graz, Austria; Division of Neonatology, Department of Pediatrics, Medical University of Graz, Graz, Austria.
authors.forename: Bernhard
authors.initials: B
authors.lastname: Schwaberger
authors.affiliation: Research Unit for Neonatal Micro- and Macrocirculation, Department of Pediatrics, Medical University of Graz, Graz, Austria; Division of Neonatology, Department of Pediatrics, Medical University of Graz, Graz, Austria.
authors.forename: Corinna
authors.initials: C
authors.lastname: Binder-Heschl
authors.affiliation: Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Graz, Austria.
authors.forename: Alexander
authors.initials: A
authors.lastname: Avian
authors.affiliation: Research Unit for Neonatal Micro- and Macrocirculation, Department of Pediatrics, Medical University of Graz, Graz, Austria; Division of Neonatology, Department of Pediatrics, Medical University of Graz, Graz, Austria.
authors.forename: Jasmin
authors.initials: J
authors.lastname: Pansy
authors.affiliation: Center for the Studies of Asphyxia and Resuscitation, Royal Alexandra Hospital, Edmonton, Canada; Department of Pediatrics, University of Alberta, Edmonton, Canada.
authors.forename: Po-Yin
authors.initials: PY
authors.lastname: Cheung
authors.affiliation: Center for the Studies of Asphyxia and Resuscitation, Royal Alexandra Hospital, Edmonton, Canada; Department of Pediatrics, University of Alberta, Edmonton, Canada.
authors.forename: Georg Marcus
authors.initials: GM
authors.lastname: Schmölzer
mesh_terms: D002560:Cerebrovascular Circulation / Q000502:physiology*; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D018496:Hyperoxia / Q000097:blood / Q000517:prevention & control*; D002534:Hypoxia, Brain / Q000097:blood / Q000517:prevention & control*; D007223:Infant; D007226:Infant Mortality; D007231:Infant, Newborn; D007234:Infant, Premature; D007363:Intensive Care Units, Neonatal; D008297:Male; D008991:Monitoring, Physiologic / Q000379:methods*; D010092:Oximetry / Q000379:methods; D010100:Oxygen / Q000097:blood; D010102:Oxygen Inhalation Therapy; D010865:Pilot Projects; D011446:Prospective Studies; D012151:Resuscitation; D019265:Spectroscopy, Near-Infrared; D013997:Time Factors
chemical_list: D010100:Oxygen