TY - JOUR
T1 - Use of selective gut decontamination in critically ill children
T2 - Protocol for the Paediatric Intensive Care and Infection Control (PICnIC) pilot study
AU - Brown, Alanna
AU - Ferrando, Paloma
AU - Popa, Mariana
AU - De La Fuente, Gema Milla
AU - Pappachan, John
AU - Cuthbertson, Brian
AU - Drikite, Laura
AU - Feltbower, Richard
AU - Gouliouris, Theodore
AU - Sale, Isobel
AU - Shulman, Robert
AU - Tume, Lyvonne N.
AU - Myburgh, John
AU - Woolfall, Kerry
AU - Harrison, David A.
AU - Mouncey, Paul R.
AU - Rowan, Kathryn M.
AU - Pathan, Nazima
N1 - Funding Information:
Funding This work was supported by NIHR HTA Programme (reference: 16/152/01).
Funding Information:
Twitter Lyvonne N Tume @LyvonneTume, Kerry Woolfall @kerry_woolfall and Nazima Pathan @drnazimapathan Acknowledgements Our thanks to the research and clinical teams at the participating sites, and the support of the Biomedical Research Centres at the sites: Cambridge University Hospitals NHS Foundation Trust, Birmingham Women and Children’s Hospital (Birmingham), Bristol Royal Hospital for Children (Bristol), John Radcliffe Hospital (Oxford), Southampton Children’s Hospital (Southampton), St. George’s Hospital (London).
Funding Information:
Competing interests NP, JP, BC, RF, TG, RS, LNT, KW, DAH, PRM, KMR, AB, PF, GMdlF, LD and MP are funded by the UK NIHR HTA research programme. KMR is the Director of NIHR Health and Social Care Delivery Research (HSDR) Programme. NP and LNT is a member of the NIHR HTA research prioritisation panel and LNT is a member of the NIHR HTA funding panel. JM is Chair of SuDDICU Australia Management Committee, Director of The George Institute for Global Health and Leadership Fellowship of National Health and Medical Research Council, Australia.
Publisher Copyright:
©
PY - 2022/3/11
Y1 - 2022/3/11
N2 - Introduction Healthcare-associated infections (HCAIs) 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 Paediatric Intensive Care and Infection Control is a parallel group pilot cRCT, with integrated mixed-methods study, comparing incorporation of SDD into infection control procedures to standard care. After a 1-week pretrial 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 (in England, UK) will begin with usual care in period 1, 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 2. 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.
AB - Introduction Healthcare-associated infections (HCAIs) 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 Paediatric Intensive Care and Infection Control is a parallel group pilot cRCT, with integrated mixed-methods study, comparing incorporation of SDD into infection control procedures to standard care. After a 1-week pretrial 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 (in England, UK) will begin with usual care in period 1, 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 2. 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.
KW - infection control
KW - microbiology
KW - paediatric intensive & critical care
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U2 - 10.1136/bmjopen-2022-061838
DO - 10.1136/bmjopen-2022-061838
M3 - Article (journal)
C2 - 35277414
AN - SCOPUS:85126389481
SN - 2044-6055
VL - 12
JO - BMJ Open
JF - BMJ Open
IS - 3
M1 - e061838
ER -