# Cerebral Oximetry–Guided Treatment and Cerebral Oxygenation in Extremely Preterm Infants: A Randomized Clinical Trial

## TL;DR

Using cerebral oximetry with a specific device and guidelines improved oxygenation stability in extremely preterm infants.

## Contribution

First trial to examine standardized oximetry treatment with a single device manufacturer in preterm infants.

## Key findings

- Intervention group had significantly lower cerebral hypoxia and hyperoxia burden compared to standard care.
- Mortality and major morbidities were similar between the groups.
- Oximetry-guided treatment improved cerebral oxygenation stability in preterm infants.

## Abstract

This randomized clinical trial investigates the effect of cerebral oximetry using a near-infrared spectroscopy device from a single manufacturer and a neonatal sensor on cerebral oxygenation stability in extremely preterm infants.

Does treatment guided by cerebral oximetry using a near-infrared spectroscopy device from a single manufacturer and a neonatal sensor improve cerebral oxygenation stability in extremely preterm infants?

In this randomized clinical trial of 100 infants born at less than 29 weeks’ gestation, the burden of cerebral hypoxia and hyperoxia was significantly lower in the intervention group compared with the standard care group.

In this study, treatment guided by cerebral oximetry improved the stability of cerebral oxygenation in extremely preterm infants.

Preterm infants are at high risk of developing brain injury, and near-infrared spectroscopy (NIRS) offers the ability to measure cerebral oxygenation. The impact of using a standardized treatment guideline combined with a single NIRS device manufacturer (Nonin Medical Inc) and neonatal sensor on cerebral oxygenation has not been previously examined.

To investigate whether cerebral oximetry with a dedicated treatment guideline improves cerebral oxygenation stability.

This was a single-blinded, 2-arm randomized clinical trial conducted from October 2021 to July 2024 at 5 tertiary neonatal intensive care units across Australia, New Zealand, and the US. Infants born at less than 29 weeks’ gestation and aged younger than 6 hours underwent 1:1 random allocation stratified by gestational age (<26 weeks and ≥26 weeks) and study site.

The intervention group received cerebral oximetry and dedicated guideline-based treatment when cerebral oxygenation was outside the range of 65% to 90%. The control group had blinded cerebral oximetry and treatment guided by standard clinical monitoring.

The burden of cerebral hypoxia and hyperoxia during the first 5 days after birth expressed as percentage hours was the primary outcome. Key secondary outcomes were mortality, morbidities before discharge, and NIRS-related skin injury.

Of 149 screened infants (53 randomized to the intervention and 51 randomized to standard care), 100 infants were included in the final analysis (median [IQR] gestational age, 27 [25-28] weeks; 48 male [48.0%]). The median (IQR) birth weight was 883 (709-1079) g. The intervention group (50 infants) had a significantly lower median (IQR) burden of hypoxia and hyperoxia of 5.7% hours (2.8% hours to 15.0% hours) compared with 39.6% hours (6.5% hours to 82.3% hours) in the standard care group (50 infants), with an adjusted reduction of 42.8% hours (95% CI, 35.6% hours to 53.3% hours; P < .001). Mortality, morbidities before discharge, and safety outcomes were comparable between groups.

In this study, treatment guided by cerebral oximetry with a single device manufacturer and a neonatal sensor significantly improved the stability of cerebral oxygenation in extremely preterm infants. Larger multicenter trials are warranted to determine if this finding leads to improved survival without brain injury.

Australian New Zealand Clinical Trials Registry registration number ACTRN12621000778886