Cerebral Oximetry in Extremely Preterm Infants

This randomized clinical trial investigates if treatment guided by cerebral oximetry monitoring during the first 72 hours after birth reduces the risk of death or moderate or severe neurodevelopmental disability and cognitive impairment at 2 years of corrected age in extremely preterm infants.QuestionDoes treatment guided by cerebral oximetry monitoring during the first 72 hours after birth reduce the risk of death or moderate or severe neurodevelopmental disability and cognitive impairment at 2 years of corrected age in extremely preterm infants?FindingsIn this 2-year follow-up of the Safeguarding the Brain of Our Smallest Children (SafeBoosC-III) randomized clinical trial including 1438 infants, death or moderate or severe neurodevelopmental disability did not differ between the cerebral oximetry group and the usual-care group, and mean Bayley cognitive scores at 2 years did not differ significantly between groups.MeaningResults reveal that the routine use of cerebral oximetry monitoring during the first 72 hours after birth in extremely preterm infants to reduce death or moderate or severe neurodevelopmental disability and cognitive impairment was not supported by this trial.ImportanceCerebral oximetry monitoring in the first 72 hours after birth has not been shown to reduce death or severe brain injury at 36 weeks' postmenstrual age in extremely preterm infants. The long-term effects remain uncertain.ObjectiveTo determine whether treatment guided by cerebral oximetry monitoring during the first 72 hours after birth reduces the risk of death or longer-term neurodevelopmental outcomes at 2 years' corrected age, compared with usual care.Design, Setting, and ParticipantsIn the phase 3 Safeguarding the Brain of Our Smallest Children (SafeBoosC-III) randomized clinical trial, we compared treatment guided by cerebral oximetry monitoring with usual care for the first 72 hours after birth. Seventy sites across 17 countries randomized 1601 infants within 6 hours of birth. Infants from 56 sites participated in this follow-up. Blinded assessors evaluated outcomes using a predefined 3-tier data model combining formal clinical assessments, parental questionnaires, and informal assessments. Data were analyzed from October to December 2024.InterventionsTreatment guided by cerebral oximetry monitoring for the first 72 hours after birth vs usual care.Main Outcomes and MeasuresThe coprimary outcomes were as follows: (1) death or moderate or severe neurodevelopmental disability and (2) Bayley cognitive composite score, both assessed at approximately 2 years' corrected age.ResultsA total of 1438 infants (mean [SD] age, 26.0 [1.3] weeks; 758 male [52.7%]) participated in this follow-up study. Participants were followed up from October 2021 to October 2024. Death or moderate or severe neurodevelopmental disability occurred in 292 of 620 infants (47.1%) in the cerebral oximetry group compared with 321 of 669 infants (48.0%) in the usual-care group (relative risk with cerebral oximetry, 0.96; 97.5% CI, 0.85-1.07; P = .45). The mean (SD) Bayley cognitive score was 92.8 (17.0) in the cerebral oximetry group compared with 93.2 (17.3) in the usual-care group (mean difference with cerebral oximetry, -0.14; 97.5% CI, -3.24 to 2.96; P = .92).Conclusions and RelevanceIn extremely preterm infants, treatment guided by cerebral oximetry monitoring compared with usual care for the first 72 hours after birth did not result in a lower incidence of death or moderate or severe neurodevelopmental disability nor higher Bayley cognitive scores at 2 years' corrected age. The routine use of cerebral oximetry monitoring during the first 72 hours after birth in extremely preterm infants to reduce neurodevelopmental disability was not supported by this trial.Trial RegistrationClinicalTrials.gov Identifier: NCT05134116