Paediatric Intensive Care and Infection Control (PICnIC)
Research type
Research Study
Full title
A pilot cluster randomised clinical trial of the use of selective gut decontamination in critically ill children
IRAS ID
239324
Contact name
Nazima Pathan
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and University of Cambridge
ISRCTN Number
ISRCTN40310490
Duration of Study in the UK
1 years, 5 months, 30 days
Research summary
The PICnIC study will test if children in paediatric intensive care units (PICUs) can benefit from receiving a treatment called Selective Digestive Decontamination (SDD). SDD has been shown to improve survival in adults, however it is used less often in children. There is no high-quality evidence to inform SDD usage in children.
Finding this evidence is important because critically ill children are at a higher risk of hospital-acquired infections (HAIs). Bacteria in the digestive tract causes many of these infections. When someone is very unwell, the number of ‘good’ bacteria found in the digestive tract reduces. As a result, ‘bad’ bacteria levels may increase and spread to other organs. This can cause severe illnesses such as pneumonia and sepsis. SDDs stop the growth of these bacteria.
PICnIC will compare SDD with standard infection control procedures, such as good hand hygiene and non-touch techniques, in children admitted to PICU.
As large clinical trials are expensive and difficult to conduct, PICnIC is an 18-month feasibility study to check that the different parts, such as recruiting patients and delivering treatment, all run smoothly. We will also interview parents of participating children to ask them how they felt about their child being included. We will ask them about how they were approached and what outcome measures would be most important to them in a full trial. We will do the same thing with hospital staff working on the trial to find out how acceptable they found the trial processes.
PICnIC will include six PICUs and recruit up to 324 children. Children will be eligible if they are admitted to PICU and expected to be on a breathing machine for at least 48 hours. The study is funded by the National Institute of Health Research’s Health Technology Assessment Programme.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
20/WM/0061
Date of REC Opinion
12 Aug 2020
REC opinion
Further Information Favourable Opinion