The management of extremely preterm infants often involves advanced monitoring to prevent brain injury. Specifically, cerebral oximetry preterm infants care has been explored as a tool to guide treatment during the critical first 72 hours of life. However, recent findings from the SafeBoosC-III randomized clinical trial suggest that this intervention may not provide the long-term benefits once hoped for by neonatologists.

The phase 3 trial investigated whether using near-infrared spectroscopy (NIRS) to monitor brain oxygenation could reduce the risk of death or neurodevelopmental disability. Researchers enrolled 1,601 infants across 70 sites in 17 countries, including major centers globally. The study compared treatment guided by cerebral oximetry versus usual care during the first 72 hours after birth. Moreover, the researchers employed a blinded assessment model to ensure the validity of the results across diverse clinical settings.

Long-Term Results of Cerebral Oximetry Preterm Infants Care

The follow-up study assessed children at approximately two years of corrected age to determine if early intervention had lasting effects. The primary outcomes included a composite of death or moderate-to-severe neurodevelopmental disability and the Bayley cognitive composite score. Additionally, researchers analyzed the data between October and December 2024 to confirm the findings.

Results indicated that death or disability occurred in 47.1% of the cerebral oximetry group and 48.0% of the usual-care group. Furthermore, the mean Bayley cognitive scores were nearly identical between the two groups, with a mean difference of only -0.14. Statistical analysis showed no significant difference, as the P-values for the composite outcome and cognitive scores were 0.45 and 0.92, respectively. Therefore, the findings provide a robust evidence base suggesting that the intervention does not alter long-term neurodevelopmental trajectories.

Consequently, the routine use of cerebral oximetry in the immediate postnatal period is not supported by this large-scale evidence. While NIRS provides real-time data on oxygenation, translating this information into improved clinical outcomes remains a significant challenge. Clinicians should continue to focus on established, evidence-based protocols for neonatal intensive care to optimize outcomes for these vulnerable patients.

FAQs

Does cerebral oximetry reduce brain injury in preterm babies?

The SafeBoosC-III trial showed that while cerebral oximetry can guide treatment, it did not significantly reduce the incidence of death or severe brain injury at 36 weeks' postmenstrual age or improve outcomes at 2 years.

What are the primary outcomes used to measure success in this trial?

The trial utilized two primary measures at 2 years' corrected age: a composite of death or moderate-to-severe neurodevelopmental disability and the Bayley cognitive composite score.

Is near-infrared spectroscopy (NIRS) safe for newborns?

NIRS is generally considered a safe, non-invasive monitoring tool. While it effectively measures brain oxygen levels, this trial indicates that using it to guide treatment in the first 72 hours does not improve long-term neurodevelopmental survival.

Disclaimer: This content is for informational and educational purposes only. It does not constitute medical advice or establish a doctor-patient relationship. Refer to the latest local and national guidelines for clinical practice.

References

Rasmussen MIS et al. Cerebral Oximetry in Extremely Preterm Infants: 2-Year Follow-Up of the SafeBoosC-III Randomized Clinical Trial. JAMA Pediatr. 2026 Apr 20. doi: 10.1001/jamapediatrics.2026.1066. PMID: 42008246.

Rasmussen MIS et al. Cerebral oximetry monitoring versus usual care for extremely preterm infants: a detailed statistical analysis plan for the 2-year follow-up of the participants of the SafeBoosC-III randomised clinical trial. Trials. 2026;27(1):15. doi: 10.1186/s13063-025-09392-7.