A paediatric intensive care study comparing the use of non-absorbable antibiotics and standard infection control to prevent secondary infection in critically ill children

Conditions

Digestive tract infection in critically ill children Infections and Infestations

Alanna Kathleen Brown, Paloma Ferrando-Vivas, M Popa, Gema Milla de la Fuente, John Pappachan et al. (18 authors)

Health Technology Assessment2024-02-014 citations

Selective digestive tract decontamination to prevent healthcare associated infections in critically ill children: the PICNIC multicentre randomised pilot clinical trial.

Pathan N, Woolfall K, Popa M, de la Fuente GM, Ferrando-Vivas P, Brown A, Gouliouris T, Tume LN, Shulman R, Cuthbertson BH, Sale I, Feltbower RG, Myburgh J, Pappachan J, Harrison D, Mouncey P, Rowan K, PICNIC study investigators.

2023-12-074 citations

10.1038/s41598-023-46232-7

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

Alanna Kathleen Brown, Paloma Ferrando, Mariana Popa, Gema Milla de la Fuente, John Pappachan et al. (18 authors)

BMJ Open2022-03-013 citations

10.1136/bmjopen-2022-061838

Interventions

The PICnIC study is a pilot, parallel group cluster randomised clinical trial (cRCT) that includes an integrated mixed methods study. We will discuss the cRCT and mixed-methods separately. The whole s

during the transition period

post-trial. Eligible patients will be: 1. AgeD >37 weeks (corrected gestational age) and <16 years 2. Receiving mechanical ventilation expected to last at least 48 h (and expected to remain so until

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Pilot cRCT: 1. Aged >37 weeks (corrected gestational age) and <16 years 2. Receiving mechanical ventilation expected to last at least 48 h (and expected to remain so until the day after tomorrow) Mixed methods study: 3. Online survey/telephone interviews: All health care professionals working in a PICU within the UK 4. Focus Groups: All healthcare professionals working in the two PICUs selected for focus groups 5. Survey/telephone interviews: Parents/legal representatives of all recruited patients

Exclusion criteria

Exclusion criteria: 1. Known allergy, sensitivity or interaction to polymyxin E, tobramycin, or nystatin 2. Known to be pregnant 3. Death perceived as imminent

Design outcomes

Primary

Measure	Time frame
Feasibility outcomes: 1. Adherence to the SDD intervention assessed by the proportion of eligible children allocated to the intervention that receive SDD using case report forms 2. Estimation of recruitment rate measured using ... 3. Questionnaires and interviews will be used to explore parents/legal representatives’ views on: the acceptability of conducting a definitive trial; the content and understanding of the information materials; acceptability of the recruitment and consenting procedures; and the selection of important, relevant, patient-centred, primary and secondary outcomes for a definitive trial. 4. Two focus groups and up to 10 interviews with practitioners involved in the pilot cRCT, as well as an online survey of all UK PICU staff will be used to assess: the acceptability of the implementation of the SDD intervention; interest in participation in a definitive trial in the wider PICU community; the acceptability of the recruitment and consenting procedures for the definitive trial; and the acceptability of collecting data for assessing the selected clinical and ecological outcomes	—

Measure

Time frame

Feasibility outcomes: 1. Adherence to the SDD intervention assessed by the proportion of eligible children allocated to the intervention that receive SDD using case report forms 2. Estimation of recruitment rate measured using ... 3. Questionnaires and interviews will be used to explore parents/legal representatives’ views on: the acceptability of conducting a definitive trial; the content and understanding of the information materials; acceptability of the recruitment and consenting procedures; and the selection of important, relevant, patient-centred, primary and secondary outcomes for a definitive trial. 4. Two focus groups and up to 10 interviews with practitioners involved in the pilot cRCT, as well as an online survey of all UK PICU staff will be used to assess: the acceptability of the implementation of the SDD intervention; interest in participation in a definitive trial in the wider PICU community; the acceptability of the recruitment and consenting procedures for the definitive trial; and the acceptability of collecting data for assessing the selected clinical and ecological outcomes

—

Secondary

Measure	Time frame
There are no secondary outcome measures	—

Countries

England, United Kingdom

Outcome results

None listed