Status: Final stages of recruitment
The Statistical Analysis Plan for PICnIC can be downloaded here
What is this study about?
Each year, around 20,000 children are admitted to paediatric intensive care units (PICUs) in the UK. Critically ill children are at a higher risk of hospital-acquired infections. Many of these infections are caused by ‘bad’ bacteria in the digestive tract, such as those in the mouth and stomach. Normally there are higher levels of ‘good’ bacteria in the digestive tract. When someone is very poorly, the number of ‘bad’ bacteria may rise and spread to other organs. This can then cause severe illnesses, such as pneumonia and sepsis, and lead to long-term health problems, increased hospital costs and even death.
All PICUs have several methods to reduce the risk of hospital-acquired infections, such as providing antibacterial gel on units. One possible method is to treat patients with antibiotics that stop the growth of bacteria in the digestive tract. This treatment is called selective decontamination of the digestive tract (SDD). It has been shown in adults to reduce the number of hospital-acquired infections and improve survival. However, it is unclear if it works in children.
Our aim is to compare giving SDD with not giving SDD (usual care) in children admitted to an NHS PICU. We also need to be sure that if SDD is used, it does not lead to a rise in resistance to antibiotics either in the patient or in the whole community.
As large clinical trials are expensive, it is important to be confident that a trial can be done and that the different components of the trial can all work together. Before embarking on a full trial, we will conduct an 18-month feasibility study including a pilot trial. A feasibility study is a piece of research done before the main trial to answer the question “Can this trial be done?” and is used to estimate important factors such as willingness of patients to take part. A pilot trial is a miniature version of the full trial and is done to check that the different components, such as recruiting patients, delivering treatment and follow-up, all run smoothly.
When is it taking place?
The study will run across 20 weeks in 2021.
Who is leading the study?
Dr Nazima Pathan, University of Cambridge
This study is funded by the National Institute for Health Research (NIHR) – Health Technology Assessment (HTA) Programme (project number: 16/152/01)