Abstract
BackgroundCerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials. The objective of the SafeBoosC III trial is to investigate the benefits and harms of treatment based on near-infrared spectroscopy (NIRS) monitoring compared with treatment as usual for extremely preterm infants.Methods/designSafeBoosC III is an investigator-initiated, multinational, randomised, pragmatic phase III clinical trial. Inclusion criteria will be infants born below 28 weeks postmenstrual age and parental informed consent (unless the site is using ‘opt-out’ or deferred consent). Exclusion criteria will be no parental informed consent (or if ‘opt-out’ is used, lack of a record that clinical staff have explained the trial and the ‘opt-out’ consent process to parents and/or a record of the parents’ decision to opt-out in the infant’s clinical file); decision not to provide full life support; and no possibility to initiate cerebral NIRS oximetry within 6 h after birth. Participants will be randomised 1:1 into either the experimental or control group. Participants in the experimental group will be monitored during the first 72 h of life with a cerebral NIRS oximeter. Cerebral hypoxia will be treated according to an evidence-based treatment guideline. Participants in the control group will not undergo cerebral oxygenation monitoring and will receive treatment as usual. Each participant will be followed up at 36 weeks postmenstrual age. The primary outcome will be a composite of either death or severe brain injury detected on any of the serial cranial ultrasound scans that are routinely performed in these infants up to 36 weeks postmenstrual age. Severe brain injury will be assessed by a person blinded to group allocation. To detect a 22% relative risk difference between the experimental and control group, we intend to randomise a cohort of 1600 infants.DiscussionTreatment guided by cerebral NIRS oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants. There is an urgent need to assess the clinical effects of NIRS monitoring among preterm neonates.Trial registrationClinicalTrial.gov, NCT03770741. Registered 10 December 2018.
Highlights
Cerebral oxygenation monitoring may reduce the risk of death and neurologic complications in extremely preterm infants, but no such effects have yet been demonstrated in preterm infants in sufficiently powered randomised clinical trials
Treatment guided by cerebral near-infrared spectroscopy (NIRS) oximetry has the potential to decrease the risk of death or survival with severe brain injury in preterm infants
After the publication of trial results, depersonalised individual patient data will be uploaded at Zenodo. In this pragmatic trial, we plan to test the hypothesis that the application of treatment based on cerebral NIRS monitoring in extremely preterm infants will decrease a composite outcome of either death or survival with severe brain injury at 36 weeks postmenstrual age
Summary
We plan to test the hypothesis that the application of treatment based on cerebral NIRS monitoring in extremely preterm infants will decrease a composite outcome of either death or survival with severe brain injury at 36 weeks postmenstrual age. When NIRS monitors show hypoxic values, neonatologists must evaluate the participant’s clinical status by taking additional measures into consideration and deciding on a possible modification of cardio-respiratory support and interventions to increase blood oxygen transport capacity, based on the treatment guideline This complexity will result in difficulty interpreting specific results, as it cannot be ascertained what exactly causes a potential effect at 36 weeks postmenstrual age. Reproducing and generalising complex interventions may be difficult for future clinicians assessing the results of this trial [40] Since this is a pragmatic effectiveness trial evaluating outcomes related to NIRS-based cerebral oxygenation monitoring in routine practice and not the specific treatment choices per se, this concern will not affect the purpose of the trial. Infrared spectroscopy; ROP: Retinopathy of prematurity; SAE: Severe adverse events; SAR: Severe adverse reactions
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