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Use of selective gut decontamination in critically ill children: PICnIC a pilot RCT and mixed-methods study
Alanna Brown1, Paloma Ferrando-Vivas1, Mariana Popa2
1Clinical Trials Unit, Intensive Care National Audit and Research Centre, London, UK.
Insights
A pilot study found that a definitive trial of selective decontamination of the digestive tract (SDD) in critically ill children is feasible. Modifications to consent and administration protocols are recommended for future trials.
Area of Science:
- Critical Care Medicine
- Pediatric Infectious Diseases
- Clinical Trial Methodology
Background:
- Healthcare-associated infections (HAIs) are a significant cause of morbidity and mortality in critically ill children.
- Selective decontamination of the digestive tract (SDD) shows promise in reducing HAIs in adults but has not been evaluated in pediatric intensive care units (PICUs).
Purpose of the Study:
- To assess the feasibility of a multicenter, cluster-randomized controlled trial (cRCT) for SDD in critically ill children.
- To compare SDD with standard infection control practices in the pediatric intensive care setting.
Main Methods:
- A parallel-group pilot cRCT with an integrated mixed-methods study was conducted across six English PICUs.
- Participants included children (up to 16 years) requiring mechanical ventilation for at least 48 hours.
- Interventions involved SDD administered as oro-pharyngeal paste and enteric tube suspension during mechanical ventilation.
Main Results:
- 368 children were enrolled, achieving an 85% eligibility rate.
- High adherence to SDD (98%) was observed, with 68% initiated within 6 hours.
- Recruitment rates exceeded targets, and the trial was deemed acceptable to parents and staff with protocol adaptations.
Conclusions:
- A definitive cRCT evaluating SDD in PICUs is feasible with specific modifications.
- Recommended adaptations include improved consent processes, staff training, and refined SDD administration protocols.
- The findings support conducting a definitive trial to maximize the efficiency of trial processes and assess SDD's impact.
Background:
Healthcare-associated infections are a major cause of morbidity and mortality in critically ill children. In adults, data suggest the use of selective decontamination of the digestive tract may reduce the incidence of healthcare-associated infections. Selective decontamination of the digestive tract has not been evaluated in the paediatric intensive care unit population.
Objectives:
To determine the feasibility of conducting a multicentre, cluster-randomised controlled trial in critically ill children comparing selective decontamination of the digestive tract with standard infection control.
Design:
Parallel-group pilot cluster-randomised controlled trial with an integrated mixed-methods study.
Setting:
Six paediatric intensive care units in England.
Participants:
Children (> 37 weeks corrected gestational age, up to 16 years) requiring mechanical ventilation expected to last for at least 48 hours were eligible for the PICnIC pilot cluster-randomised controlled trial. During the ecology periods, all children admitted to the paediatric intensive care units were eligible. Parents/legal guardians of recruited patients and healthcare professionals working in paediatric intensive care units were eligible for inclusion in the mixed-methods study.
Interventions:
The interventions in the PICnIC pilot cluster-randomised controlled trial included administration of selective decontamination of the digestive tract as oro-pharyngeal paste and as a suspension given by enteric tube during the period of mechanical ventilation.
Main Outcome Measures:
The decision as to whether a definitive cluster-randomised controlled trial is feasible is based on multiple outcomes, including (but not limited to): (1) willingness and ability to recruit eligible patients; (2) adherence to the selective decontamination of the digestive tract intervention; (3) acceptability of the definitive cluster-randomised controlled trial; (4) estimation of recruitment rate; and (5) understanding of potential clinical and ecological outcome measures.
Results:
A total of 368 children (85% of all those who were eligible) were enrolled in the PICnIC pilot cluster-randomised controlled trial across six paediatric intensive care units: 207 in the baseline phase (Period One) and 161 in the intervention period (Period Two). In sites delivering selective decontamination of the digestive tract, the majority (98%) of children received at least one dose of selective decontamination of the digestive tract, and of these, 68% commenced within the first 6 hours. Consent for the collection of additional swabs was low (44%), though data completeness for potential outcomes, including microbiology data from routine clinical swab testing, was excellent. Recruited children were representative of the wider paediatric intensive care unit population. Overall, 3.6 children/site/week were recruited compared with the potential recruitment rate for a definitive cluster-randomised controlled trial of 3 children/site/week, based on data from all UK paediatric intensive care units. The proposed trial, including consent and selective decontamination of the digestive tract, was acceptable to parents and staff with adaptations, including training to improve consent and communication, and adaptations to the administration protocol for the paste and ecology monitoring. Clinical outcomes that were considered important included duration of organ failure and hospital stay, healthcare-acquired infections and survival.
Limitations:
The delivery of the pilot cluster-randomised controlled trial was disrupted by the COVID-19 pandemic, which led to slow set-up of sites, and a lack of face-to face training.
Conclusions:
PICnIC's findings indicate that a definitive cluster-randomised controlled trial in selective decontamination of the digestive tract in paediatric intensive care units is feasible with the inclusion modifications, which would need to be included in a definitive cluster-randomised controlled trial to ensure that the efficiency of trial processes is maximised.
Future Work:
A definitive trial that incorporates the protocol adaptations and outcomes arising from this study is feasible and should be conducted.
Trial Registration:
This trial is registered as ISRCTN40310490.
Funding:
This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 16/152/01) and is published in full in Health Technology Assessment; Vol. 28, No. 8. See the NIHR Funding and Awards website for further award information.
