Use of selective gut decontamination in critically ill children : protocol for the Paediatric Intensive Care and Infection Control (PICnIC) pilot study

Brown, A; Ferrando-Vivas, P; Popa, M; Milla de la Fuente, G; Tume, J; Cuthbertson, B; Drikite, L; Feltbower, R; Gouliouris, T; Sale, I; Shulman, R; Tume, LN; Myburgh, J; Woolfall, K; Harrison, D; Mouncey, P; Rowan, K; Pathan, N

Abstract

Introduction:
Healthcare-associated infections (HCAI) are a major cause of morbidity and mortality in critically ill children. In critically ill adults, there are data that suggest the use of Selective Decontamination of the Digestive tract (SDD), alongside standard infection control measures reduce mortality and the incidence of HCAIs. SDD-enhanced infection control has not been compared directly with standard infection prevention strategies in the Paediatric Intensive Care Unit (PICU) population. The aim of this pilot study is to determine the feasibility of conducting a multicentre cluster randomised controlled trial (cRCT) in critically ill children comparing SDD with standard infection control.

Methods and analysis:
PICnIC is a parallel group pilot cRCT, with integrated mixed-methods study, comparing incorporation of SDD into infection control procedures to standard care. After a one week pre-trial ecology surveillance period, recruitment to the cRCT will run for a period of 18 weeks, comprising: (1) baseline control period (2) pre, mid and post-trial ecology surveillance periods and (3) intervention period. Six PICUs (based in England, UK) will begin with usual care in Period One, then will be randomised 1:1 by the trial statistician using computer-based randomisation, to either continue to deliver usual care or commence delivery of the intervention (SDD) in Period Two. Outcomes measures include parent and healthcare professionals’ views on trial feasibility, adherence to the SDD intervention, estimation of recruitment rate and understanding of potential patient-centred primary and secondary outcome measures for the definitive trial. The planned recruitment for the cRCT is 324 participants.

Ethics and dissemination:
The trial received favourable ethical opinion from West Midlands – Black Country Research Ethics Committee (reference: 20/WM/0061) and approval from the Health Research Authority (IRAS number: 239324). Informed consent is not required for SDD intervention or anonymised data collection but is sought for investigations as part of the study, any identifiable data collected and monitoring of medical records. Results will be disseminated via publications in peer-reviewed medical journals.

Trial registration number:
ISRCTN40310490

Strengths and limitation of this study:
• The study will examine the processes that are important in a future clinical trial of SDD in the PICU setting.

• The study uses a GMP-certified commercial SDD preparation under licence from the George Institute, Australia (Verita Pharma Pty, Australia).

• The study will evaluate the perspective of parents and the views of stakeholders including caregivers and the multi-disciplinary team on the processes needed to undertake a trial of SDD in the PICU.

• The use of SDD-enhanced infection control requires it to be implemented unit-wide, along with the support of local microbiology, pharmacy and infection control teams for delivery and monitoring in sites randomised to implement it.

• This is a pilot study, so is not designed to assess effectiveness of the intervention. The study outcomes will inform the feasibility of a future trial based on clinical outcomes.

Citation

Brown, A., Ferrando-Vivas, P., Popa, M., Milla de la Fuente, G., Tume, J., Cuthbertson, B., …Pathan, N. (2022). Use of selective gut decontamination in critically ill children : protocol for the Paediatric Intensive Care and Infection Control (PICnIC) pilot study. BMJ Open, 12(3), e061838. https://doi.org/10.1136/bmjopen-2022-061838

• Journal Article Type: Article
• Acceptance Date: Feb 15, 2022
• Publication Date: Mar 11, 2022
• Deposit Date: Feb 15, 2022
• Publicly Available Date: Mar 23, 2022
• Journal: BMJ Open
• Publisher: BMJ Publishing Group
• Volume: 12
• Issue: 3
• Pages: e061838
• DOI: https://doi.org/10.1136/bmjopen-2022-061838
• Publisher URL: https://doi.org/10.1136/bmjopen-2022-061838
• Related Public URLs: http://bmjopen.bmj.com/
• Additional Information: Projects : A pilot cluster randomised clinical trial of the use of selective gut decontamination in critically ill children (Paediatric Intensive Care and Infection Control: PICnIC)