Breathing and brain development, version 1.0
Research type
Research Study
Full title
Breathing and brain development in premature infants
IRAS ID
265473
Contact name
Caroline Hartley
Contact email
Sponsor organisation
University of Oxford, Clinical Trials and Research Governance
Duration of Study in the UK
4 years, 10 months, 31 days
Research summary
1 in 10 babies are born prematurely (more than 3 weeks early), which can have a long-term impact on brain function and IQ (intelligence quotient). However, what drives these long-term effects is poorly understood. Premature infants often experience apnoea – pauses in breathing – which can result in decreased oxygen supply to the brain. Yet the impact of frequent episodes of apnoea on brain development is unclear. The aim of this study is to investigate whether apnoea alters brain development in premature infants, and to determine how this relates to cognitive ability at 2 years of age. A total of 80 infants born between 28 – 32 weeks’ gestation will be studied. Their ‘vital signs’ (such as breathing rate, heart rate and oxygen saturation levels), which are continuously monitored as part of their standard neonatal care, will be electronically recorded from the time at which they enter the study until discharge from hospital. Brain activity will be recorded once a week until hospital discharge using EEG (electroencephalography) to ascertain the relative maturity of the infant’s brain development. At approximately 2 years of age participant’s cognitive ability will be assessed using the Bayley Scale of Infant Development, a standardised assessment measure. The primary outcome will be to assess associations between the frequency and severity of apnoea and cognitive ability. The relationship between apnoea with week-to-week changes in the maturity of the infant’s brain development will be assessed, adjusting for factors such as the infant’s gestational age at birth and any medical conditions. This research will enhance our understanding of apnoea and the long-term effects of premature birth.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1085
Date of REC Opinion
24 Jul 2019
REC opinion
Further Information Favourable Opinion