Safeguarding the Brain Of Our Smallest Children- an open-label phase-III randomsied trial of cerebral oximetry combined with a treatment guideline versus treatment as usual in premature infants

Approximately 25,000 preterm infants are born more than 12 weeks early every year in Europe. For these preterm infants, the consequences of such an early birth include a high risk of death and brain injury. About one in five will die and almost one quarter of all survivors will be at risk of longer-term developmental problems. Preventive measures are key to reducing these problems. Monitoring the oxygen levels in the brain can be readily done very safely at the bedside with near-infrared light (NIRS). 

NIRS has been used in newborn care for over 30 years, but mainly as a research tool and has not been used routinely in clinical practice. This type of monitoring is called cerebral (brain) oxygenation monitoring and has been shown to reduce the length of stay in intensive care as well as the risk of brain complications in adults and children, but these benefits have not been studied appropriately in preterm infants.

The overall aim of this project is to evaluate a new approach to caring for preterm infants in the first days of life: a move to targeting brain orientated care by monitoring oxygen levels in the brain. This is achieved very easily with a sensor placed on the forehead. We have already shown that this monitoring can occur easily in preterm infants in the first days of life. We have studied it in eight European countries and found it to be safe and reduces the time a baby has low brain oxygen levels. This is a novel approach to a complex problem, delivering more personalised care. 

We are leading the Irish arm of this project and aim to  recruit up to 140 preterm babies at four large neonatal units. We will also evaluate clinicians' and parents' views of the consent process in newborn trials
 

Award Date

04 December 2020

Award Value

€€982,517.90

Principal Investigator

Professor Eugene Dempsey

Host Institution

University College Cork

Scheme

DIFA 2020