Neonatal Real World Data project
Research type
Research Study
Full title
Advancing standards and methodologies to generate real world evidence from real world data through a neonatal pilot project
IRAS ID
299791
Contact name
Mark Turner
Contact email
Sponsor organisation
Critical Path Institute
Duration of Study in the UK
2 years, 2 months, 30 days
Research summary
Drug development in newborn and premature infants lags significantly behind adults and children. There is an urgent need to advance the development of treatments that improve their survival and outcome. However, there is minimal new drug development and most existing drugs have insufficient evidence to support safety, effectiveness, and dosage in this high-risk population. One important barrier to research is a lack of information about the diseases that premature babies suffer from and information about the results of laboratory tests on these babies. This project will develop a database that will collect data from multiple sources and use the data to answer specific questions in neonatal care. Pre-existing de-identified data from data from clinical trials, electronic medical records, and registries will be gathered into a central secure data repository. Using this information, we will perform an analysis that generates neonatal laboratory test reference ranges and a summary of what happens (a disease progression model) to babies who develop bronchopulmonary dysplasia (BPD) – a chronic lung disease of premature infants.
REC name
Wales REC 5
REC reference
21/WA/0320
Date of REC Opinion
28 Oct 2021
REC opinion
Favourable Opinion