In-line filtration in very preterm neonates: a randomized controlled trial

Anne-Laure Virlouvet,Emilie Guerriero,Thomas Storme,Aurélie Bourmaud,Andreas Capewell,Stéphane Rioualen,Valérie Biran,Marina Colella,Artemis Toumazi,Olivier Baud,Julien Pansiot

doi:10.1038/s41598-020-61815-4

Abstract

In-line filtration is increasingly used in critically-ill infants but its benefits, by preventing micro-particle infusion in very preterm neonates, remain to be demonstrated. We conducted a randomized controlled trial among very preterm infants allocated to receive either in-line filtration of all the intra-venous lines or standard care without filters. The primary outcome was differences greater than 20% in the median changes in pro-inflammatory cytokine serum concentrations measured at day 3 and day 8 (+/−1) using a Luminex multianalytic profiling technique. Major neonatal complications were analyzed as secondary predefined outcomes. We randomized 146 infants, assigned to filter (n = 73) or control (n = 73) group. Difference over 20% in pro-inflammatory cytokine concentration between day 3 and day 8 was not found statistically different between the two groups, both in intent-to-treat (with imputation) and per protocol (without imputation) analyses. The incidences of most of neonatal complications were found to be similar. Hence, this trial did not evidence a beneficial effect of in-line filtration in very preterm infants on the inflammatory response syndrome and neonatal morbidities. These data should be interpreted according to local standards in infusion preparation and central line management.

Highlights

In-line filtration is increasingly used in critically-ill infants but its benefits, by preventing micro-particle infusion in very preterm neonates, remain to be demonstrated
This primary outcome was analyzed as intent-to-treat after multiple imputations (ITT) and as per protocol (PP)
It should be noted that due to the automated counting method small particles

Summary

Introduction

In-line filtration is increasingly used in critically-ill infants but its benefits, by preventing micro-particle infusion in very preterm neonates, remain to be demonstrated. The incidences of most of neonatal complications were found to be similar This trial did not evidence a beneficial effect of in-line filtration in very preterm infants on the inflammatory response syndrome and neonatal morbidities. These data should be interpreted according to local standards in infusion preparation and central line management. There is still insufficient evidence to recommend the use of IV in-line filters in very preterm infants, especially in settings of neonatal intensive care units with high standards for infusion preparation and central line management[28]. We hypothesized that a reduction in circulating cytokine levels

Methods

Results

Conclusion