Amplitude integrated EEG in preterm infants - a feasibility study
Research type
Research Study
Full title
Amplitude integrated electroencephalography (aEEG) monitoring in preterm infants - a feasibility study
IRAS ID
227626
Contact name
Anthony R Hart
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 28 days
Research summary
Research Summary:
Premature babies on neonatal units are monitored continuously to help neonatal staff recognise when they are unwell and to treat them early. Brain injury is common in premature babies, and can lead to learning difficulties and cerebral palsy, yet monitoring of brain function is not routine.Amplitude integrated encephalography (aEEG) monitors brain activity by attaching leads to a baby’s head and is used routinely in sick term babies after a difficult birth. We do not know how useful aEEG is in premature babies, but small studies suggest it is altered by brain injury, infections, drugs, changes in blood pressure and acid levels. If we can detect aEEG changes in premature babies early, neonatal staff might be able to change treatment to make them better.
This is a feasibility study. We will examine how many families agree to us monitoring their baby’s brain activity with aEEG, and what problems we will face in future studies. Our study has two phases. In phase one we will recruit 6 babies born between 26+0 and 30+0 without genetic disorders or structural brain abnormalities to have aEEG monitoring for one week. This will demonstrate that recruitment to the study is possible. In phase two we will recruit babies of the same gestational age to have continuous aEEG whilst on intensive care, and four hours a week until discharge home. Participants in phase two will receive a standardised neurological examination and MRI of the brain prior to discharge. The parents and staff caring for participants in phase two will complete a questionnaire on their experiences of aEEG monitoring.
The data from this study will enable us to design and power larger studies to evaluate whether aEEG monitoring can improve treatment and prognosis in premature babies.
Lay summary of study results:
No evidence to suggest results have been published in the suggested journals stated in the study protocol.REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
17/YH/0253
Date of REC Opinion
23 Aug 2017
REC opinion
Further Information Favourable Opinion