Gerhard Pichler1, Berndt Urlesberger1, Nariae Baik1, Bernhard Schwaberger1, Corinna Binder-Heschl1, Alexander Avian2, Jasmin Pansy1, Po-Yin Cheung3, Georg Marcus Schmölzer3. 1. 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. 2. Institute for Medical Informatics, Statistics and Documentation, Medical University of Graz, Graz, Austria. 3. Center for the Studies of Asphyxia and Resuscitation, Royal Alexandra Hospital, Edmonton, Canada; Department of Pediatrics, University of Alberta, Edmonton, Canada.
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. STUDY DESIGN: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. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02017691.
RCT Entities:
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 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. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02017691.
Authors: Ena Suppan; Gerhard Pichler; Corinna Binder-Heschl; Bernhard Schwaberger; Berndt Urlesberger Journal: Front Pediatr Date: 2022-06-13 Impact factor: 3.569
Authors: Anup C Katheria; Jeff M Szychowski; Jochen Essers; Marc R Mendler; Eugene M Dempsey; Georg M Schmölzer; Kathy Arnell; Wade D Rich; Kasim Hassen; Phillip Allman; Michael Varner; Gary R Cutter; Neil Finer Journal: J Pediatr Date: 2020-05-29 Impact factor: 4.406