Cerebral Oximetry-Guided Treatment and Cerebral Oxygenation in Extremely Preterm Infants: A Randomized Clinical Trial.

IMPORTANCE

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.

OBJECTIVE

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

DESIGN, SETTING, AND

PARTICIPANTS

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.

INTERVENTION: 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.

MAIN OUTCOMES AND MEASURES: 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.

RESULTS

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.

CONCLUSIONS AND RELEVANCE: 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.

TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry registration number ACTRN12621000778886.