Synthesizing Real World Data, systematic reviews, patient and public input, expert consensus and clinical staff perspectives to develop and pilot a master protocol for an adaptive platform trial of neonatal sepsis management
Lead: Dr Julia Bielicki, Reader in Paediatric Infectious Diseases, CNPI, St George’s University of London
Funder
NIHR Advanced Fellowship
Duration
4 years
Type of Study
Preparatory work for an adaptive platform trial
Summary
This project focuses on newborn babies in hospital who are being treated for a serious infection. The goal is develop a so-called adaptive platform trial that could study multiple types of treatment while reducing the burden on babies, families and staff.
Newborn babies are vulnerable to infections caused by bacteria (or bugs), so antibiotics are given as soon as a doctor suspects an infection. There are many different antibiotics used to treat infections in babies, and it is often unclear which to prescribe. Antibiotics can be given at different doses and lengths of time, and it is often not known which work best. A certain antibiotic, dose or length of treatment could be problematic because the good bugs living in the baby’s gut could be altered or become resistant to antibiotics. Antibiotics may then not work as well for future infections.
The best way to study treatments is in a clinical trial, which is often challenging. Parents and staff find infections worrying and struggle to consider whether it is right for their baby or patient to take part. Babies with different problems are looked after on neonatal units, for example those born too early or with surgical conditions. This makes it difficult to decide whether a certain antibiotic, dose or treatment length will work well for any individual baby. Also, identifying any unwanted effects of a treatment is hard because babies in neonatal units have many problems and it is not clear which are related to the treatment.
This project will work out how some of these challenges can be addressed. National and international experts as well as parents and staff from UK neonatal units will be asked to give feedback on key elements of a trial to study best treatments of newborn infection. This will include how best to identify babies for whom questions of treatment of infection are important, how to ensure that treatments are safe and how to provide information about the trial to parents and staff. The project will produce a set of tools that can be used by researchers in the field and a full protocol for a new trial. The trial will be of a special kind that can be used to answer many questions for babies with different characteristics at the same time, called an adaptive platform trial. Adaptive trials tend to be faster and more efficient than traditional trials, which should hopefully result in better treatments being made available to newborn babies with infection faster as well. The results of this project will do all the preparation and design for such a trial in the UK, which could change how babies with infections are treated in the future.
Project Duration: January 2023 – April 2027
Want to join our PPI group?
We are looking for participants who are NICU parents, NICU clinicians and NICU nurses, please fill-in your details in the form below if you are interested in taking part in our patient and public involvement sessions and help us design the way we set the project up.
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