Cerebral Oxygen Saturation to Guide Oxygen Delivery in Preterm Neonates for the Immediate Transition after Birth: A 2-Center Randomized Controlled Pilot Feasibility Trial

J Pediatr. 2016 Mar:170:73-8.e1-4. doi: 10.1016/j.jpeds.2015.11.053. Epub 2015 Dec 30.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Cerebrovascular Circulation / physiology*
  • Feasibility Studies
  • Female
  • Humans
  • Hyperoxia / blood
  • Hyperoxia / prevention & control*
  • Hypoxia, Brain / blood
  • Hypoxia, Brain / prevention & control*
  • Infant
  • Infant Mortality
  • Infant, Newborn
  • Infant, Premature*
  • Intensive Care Units, Neonatal
  • Male
  • Monitoring, Physiologic / methods*
  • Oximetry / methods
  • Oxygen / blood
  • Oxygen Inhalation Therapy*
  • Pilot Projects
  • Prospective Studies
  • Resuscitation
  • Spectroscopy, Near-Infrared
  • Time Factors

Substances

  • Oxygen

Associated data

  • ClinicalTrials.gov/NCT02017691