PRemature Infant Outcome Risk study
Research type
Research Study
Full title
Prospective observational study on premature infant outcome risk
IRAS ID
316668
Contact name
Don Sharkey
Contact email
Sponsor organisation
University of Nottingham
Duration of Study in the UK
2 years, 11 months, 28 days
Research summary
Every year in the UK, almost 8,000 babies born >8weeks early need intensive care. Sadly, nearly 900 will die and many more will develop severe diseases. Premature babies have complex needs requiring personalised care. This requires clinicians to analyse large amounts of information from multiple sources. We have developed a prediction calculator to identify babies at high risk of dying or developing serious diseases using routinely recorded healthcare data. The calculator will support timely personalised treatment decisions. This study will determine how well the calculator performs in clinical practice and compare its performance with previously developed calculators. \n\nWe will test how well the tool works in clinical practice by studying 1,300 premature babies born before 32 weeks of pregnancy until two years of age. There will be an opportunity to continue participating in future follow-up studies after two years of age with further provided around two years of age. . \n\nThis is an observational study without any changes to the care provided. The study involves extracting pseudonymised clinical neonatal data from the electronic patient record called BadgerNet. All data collected are as part of routine clinical care, without further direct contact or active participation with patients. No extra investigations will be carried out. Most of the data collected are already entered on BadgerNet. A small number of additional data items not currently entered onto BadgerNet but routinely recorded in patients’ case notes will be collected by incorporating them into BadgerNet. \n\nThe study will use the robust established pathway for extracting the BadgerNet neonatal data using an opt-out approach that is well accepted by parents and clinicians. Data on all babies admitted to participating units by 24 hours old are included in the research unless a parent refuses. This approach has been established for neonatal benchmarking and research for over a decade.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
23/WM/0011
Date of REC Opinion
15 Feb 2023
REC opinion
Further Information Favourable Opinion