Targeted Cerebral Oxygenation Using Dedicated Treatment Versus Usual Care in Extremely Preterm Infants: Protocol for a Multicentre International Phase II Randomised Controlled Trial.

Abstract

Background: Near infrared spectroscopy (NIRS) allows continuous monitoring of cerebral oxygenation and therefore has the potential to be neuroprotective. Recurrent episodes of cerebral hypo-and/or hyperoxia may result in brain injury. The Safe-BoosC-II study reported stable cerebral oxygenation in extremely preterm infants by combining a dedicated treatment guideline with NIRS monitoring using several devices and adult sensors. The ability to maintain stable cerebral oxygenation with a dedicated treatment algorithm using one type of NIRS device with neonatal sensors has not been previously investigated.

Methods: In this multicentre, 2-arm, parallel, single-blinded, phase II RCT, stratified by gestation and hospital site, 100 participants born < 29 weeks' gestation (inborn and outborns, singleton and twins) will be randomised to targeted cerebral oxygenation using dedicated treatment or usual care with blinded cerebral NIRS monitoring for the first 5 days of life. We will exclude infants > 6 h of age, those with congenital anomaly requiring major surgery or a genetic disorder, and triples or higher multiple births. The primary outcome is the burden of cerebral hypoxia and hyperoxia for the first 5 days after birth expressed as percent hours.

Discussion: The findings of this trial will provide essential information on (i) validating results from the Safe-BoosC-II study, considering the differences in the study methodology between the two trials (ii) strengthening support for routine use of cerebral NIRS monitoring in this population and (iii) informing the design of future RCTs on the effects of targeted cerebral oxygenation on neurodevelopment in early childhood as the primary outcome.

Trial registration: Australian New Zealand Clinical Trials Registry registration number ACTRN12621000778886.