article · Trials
Newborns who require invasive mechanical ventilation face significant risks of death, neurodevelopmental issues, and prolonged stays in hospital. Monitoring brain oxygen levels using cerebral oximetry to guide clinical interventions has been proposed as a way to reduce these adverse outcomes. This protocol sets out the statistical analysis plan for the first phase of the SafeBoosC-IIIv study, an international, multicentre, randomised clinical trial. The study compares treatment guided by cerebral oximetry against standard care. It plans to enrol 1610 infants born at 28 weeks of gestation or later who require intubation for at least 24 hours. The primary objective is to evaluate whether guided monitoring increases the number of days infants spend alive and outside the hospital within 90 days following randomisation, using pre-specified statistical approaches.
Critically ill newborns on breathing machines often experience complications that cause prolonged hospitalisation and long-term harm. Establishing a rigorous statistical protocol prior to completing the clinical trial ensures the evaluation of cerebral oximetry monitoring remains unbiased. If effective, this intervention could help clinical teams adjust therapies to protect newborn brains and accelerate recovery.
The work could validate clinical protocols for medical device manufacturers and neonatal intensive care units that use cerebral oximetry monitors. The primary users would be hospital clinicians managing ventilated neonates. Because this document is a statistical analysis plan for an ongoing clinical trial, real-world clinical adoption and commercial impact remain dependent on the future delivery and reporting of final trial results.
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BACKGROUND: Newborns requiring invasive mechanical ventilation are at high risk of neurodevelopmental impairment, prolonged hospitalisation, and increased mortality. Treatment guided by cerebral oximetry monitoring has been proposed to reduce morbidity and mortality. METHODS: The SafeBoosC-IIIv trial is a multicentre, parallel-group, randomised clinical trial. The trial will be conducted in two steps. This is a statistical analysis plan for step one. The objective of step one is to assess whether treatment guided by cerebral oximetry monitoring, compared with usual care, increases the number of hospital-free days in newborns receiving invasive mechanical ventilation. Inclusion criteria are gestational age ≥ 28 + 0 weeks, postnatal age less than 28 days, expected to receive invasive mechanical ventilation (intubation) for at least 24 h, and a cerebral oximeter available so monitoring can be started within 6 h after initiation of invasive mechanical ventilation. Exclusion criteria are suspicion of or confirmed brain injury or congenital heart malformation likely to require surgery. A total of 1610 participants will be randomised 1:1 to treatment guided by cerebral oximetry monitoring or usual care. The primary outcome will be hospital-free days within 90 days of randomisation, which will be analysed with the van Elteren test stratified by 'centre'. This statistical analysis plan provides a detailed description of the planned analyses, including methods for handling missing data and assessing statistical assumptions. Analyses will follow the intention-to-treat principle and will be performed independently by two statisticians. CONCLUSION: This statistical analysis plan describes the planned statistical analyses in detail for step one of the SafeBoosC-IIIv trial. TRIAL REGISTRATION: ClinicalTrials.gov NCT05907317. First submitted on 8 June 2023, https://clinicaltrials.gov/study/NCT05907317 .
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DOI: 10.1186/s13063-025-09387-4
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