Abstract
Background: Near-infrared spectroscopy (NIRS) allows non-invasive monitoring and targeting of cerebral oxygenation potentially reducing brain injury. In infants born < 29 weeks gestation, does NIRS monitoring using a single device with a dedicated treatment guideline compared to blinded NIRS monitoring with standard care, reduce the burden of cerebral hypoxia and hyperoxia in the first 5 days after birth (ACTRN12621000778886)?
Methods: With explicit or deferred consent, we randomly allocated singletons or twins to the intervention or standard care group stratified by gestational age (< 26 weeks and ≥ 26+0–28+6 weeks) and study site. The target range for the primary outcome was 65%–90%, measured using a neonatal sensor and Nonin SenSmart oximeter. The secondary clinical outcomes before hospital discharge were measured.
Results: From October 2021 to July 2024, we enrolled 103 infants and 101 were included in the final analysis. The median gestational age was 27 weeks (IQR 25–28) and the median birth weight was 875 g (IQR 710–1068). In the intervention group (n = 51), the median burden of hypoxia and hyperoxia was 4.43% hours (IQR 1.8–13.05) compared to 36.74% hours (IQR 6.03–77.12) in the control group (n = 50), a reduction of 23.75% hours (95% CI 11.21–41.02, p < 0.0001). Two infants, 1 in each group, died in the first 5 days after birth.
Conclusions: In infants born prematurely, NIRS monitoring, using a single device along with a dedicated treatment guideline, reduced the burden of cerebral hypoxia and hyperoxia in the first 5 days after birth. The results will inform future trials on improving neurodevelopment.
Oral presentation.