Investigating Cerebral Oxygenation in the Newborn (ICON). Version 1.0.
Research type
Research Study
Full title
Investigating Cerebral Oxygenation in the Newborn: An Observational Study Investigating Cerebral Oxygenation in Newborn Infants at High Risk of Brain Injury.
IRAS ID
309692
Contact name
Nikki Robertson
Contact email
Sponsor organisation
University of Edinburgh
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Despite advances in newborn intensive care, several groups of newborn babies are at risk of brain injury and associated life-long consequences. Neonatal neuro-critical care (NNC) programmes, which aim to improve neurodevelopmental outcomes, are increasingly common in neonatal units. One element of NNC is neuromonitoring (using equipment to monitor brain function). Our study uses a neuromonitoring device called near-infrared spectroscopy (NIRS). NIRS uses light to measure oxygen levels in the brain (cerebral oxygenation). It is safe and already used in clinical practice.
Our study is an observational study and will not affect routine clinical care. We will include two groups of babies.
The first group includes term babies with hypoxic ischaemic encephalopathy (HIE), which occurs due to inadequate oxygen delivery to the brain during labour. These babies undergo cooling treatment to protect the brain, however, the risk of adverse outcomes remains high. Therefore, several new treatments are currently under investigation. Currently, the best marker for later outcomes is magnetic resonance spectroscopy (MRS) imaging, which is only performed after cooling is completed. We aim to understand how using NIRS during cooling may contribute to earlier recognition of babies with evolving brain injury who may benefit from emerging therapies.
The second group comprises babies born extremely prematurely (<28 weeks of pregnancy), in whom the developing brain is vulnerable to changes in oxygen levels. In this group we will investigate how oxygen levels change during periods of skin-to-skin care in babies with brain injury compared to those without. We will also investigate how bronchopulmonary dysplasia, a chronic lung disease of prematurity, affects oxygen levels in the brain once babies reach 36 weeks corrected gestational age.
Overall, we hope to further our understanding of how changes in oxygen levels in the brain may contribute to, and serve as a marker of, brain injury in vulnerable infants.
REC name
South East Scotland REC 01
REC reference
22/SS/0098
Date of REC Opinion
10 May 2023
REC opinion
Further Information Favourable Opinion