Treatment guided by cerebral oximetry in mechanically ventilated newborns: a statistical analysis plan for step one of the SafeBoosC-IIIv randomised clinical trial.

ABSTRACT:

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 inv

SUBMITTER: Petersen JJ 

PROVIDER: S-EPMC12821886 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature