• Heather Lambert, Shaun Hiu, Malcolm G Coulthard, MatthewsJohn N SJNSBiostatistics Research Group, Population Health Sciences Institute, Newcastle University, Newcastle Upon Tyne, United Kingdom.School of Mathematics, Statistics & Physics, Newcastle University, Newcastle Upon Tyne, United Kingdom., Eva-Maria Holstein, Jean Crosier, Rachel Agbeko, Thomas Brick, Heather Duncan, David Grant, Quen Mok, Andrew Gustaf Nyman, John Pappachan, Chris Boucher, Joe Bulmer, Denise Chisholm, Kirsten Cromie, Victoria Emmet, Richard G Feltbower, Arunoday Ghose, Michael Grayling, Rebecca Harrison, Ciara A Kennedy, Elaine McColl, Kevin Morris, Lee Norman, Julie Office, Roger Parslow, Christine Pattinson, Shriya Sharma, Jonathan Smith, Alison Steel, Rachel Steel, Jayne Straker, Lamprini Vrana, Jenn Walker, Paul Wellman, Mike Whitaker, Jim Wightman, Nina Wilson, Lucy Wirz, and Ruth Wood.
• Paediatric Nephrology Department, Great North Children's Hospital, Royal Victoria Infirmary, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, United Kingdom.
• Pediatr Crit Care Me. 2023 Jul 1; 24 (7): 604613604-613.

ObjectivesRenal replacement therapy (RRT) options are limited for small babies because of lack of available technology. We investigated the precision of ultrafiltration, biochemical clearances, clinical efficacy, outcomes, and safety profile for a novel non-Conformité Européenne-marked hemodialysis device for babies under 8 kg, the Newcastle Infant Dialysis Ultrafiltration System (NIDUS), compared with the current options of peritoneal dialysis (PD) or continuous venovenous hemofiltration (CVVH).DesignNonblinded cluster-randomized cross-sectional stepped-wedge design with four periods, three sequences, and two clusters per sequence.SettingClusters were six U.K. PICUs.PatientsBabies less than 8 kg requiring RRT for fluid overload or biochemical disturbance.InterventionsIn controls, RRT was delivered by PD or CVVH, and in interventions, NIDUS was used. The primary outcome was precision of ultrafiltration compared with prescription; secondary outcomes included biochemical clearances.Measurements And Main ResultsAt closure, 97 participants were recruited from the six PICUs (62 control and 35 intervention). The primary outcome, obtained from 62 control and 21 intervention patients, showed that ultrafiltration with NIDUS was closer to that prescribed than with control: sd controls, 18.75, intervention, 2.95 (mL/hr); adjusted ratio, 0.13; 95% CI, 0.03-0.71; p = 0.018. Creatinine clearance was smallest and least variable for PD (mean, sd ) = (0.08, 0.03) mL/min/kg, larger for NIDUS (0.46, 0.30), and largest for CVVH (1.20, 0.72). Adverse events were reported in all groups. In this critically ill population with multiple organ failure, mortality was lowest for PD and highest for CVVH, with NIDUS in between.ConclusionsNIDUS delivers accurate, controllable fluid removal and adequate clearances, indicating that it has important potential alongside other modalities for infant RRT.Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies.

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