Use of selective gut decontamination in critically ill children: PICnIC a pilot RCT and mixed-methods study

• Published in: Health technology assessment (Winchester, England) England), 2024-02, Vol.28 (8), p.1-84
• Main Authors: Brown, Alanna, Ferrando-Vivas, Paloma, Popa, Mariana, de la Fuente, Gema Milla, Pappachan, John, Cuthbertson, Brian H, Drikite, Laura, Feltbower, Richard, Gouliouris, Theodore, Sale, Isobel, Shulman, Robert, Tume, Lyvonne N, Myburgh, John, Woolfall, Kerry, Harrison, David A, Mouncey, Paul R, Rowan, Kathryn, Pathan, Nazima
• Format: Article
• Language: English
• Subjects: antimicrobial therapy; antimicrobialresistance; healthcare acquired infection; infection control; sdd; selective digestive decontamination
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/HDKV1008

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. 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. Parallel-group pilot cluster-randomised controlled trial with an integrated mixed-methods study. Six paediatric intensive care units in England. 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. 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. 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. 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 swa