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Sci Rep. 2020 Mar 19;10(1):5003. doi: 10.1038/s41598-020-61815-4.

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

Author information

1
Assistance Publique-Hôpitaux de Paris, Neonatal intensive care unit, Robert Debré children's hospital, Paris, France.
2
Delegation Paris 7, Inserm U1141, University of Paris, Paris, France.
3
Assistance Publique-Hôpitaux de Paris, Unit of Clinical Epidemiology, Robert Debré children's hospital, University of Paris, Inserm U1123 and CIC-EC, 1426, Paris, France.
4
Pall Medical, SLS, Dreieich, Germany.
5
Assistance Publique-Hôpitaux de Paris, Department of Pharmacy, Robert Debré children's hospital, Paris, France.
6
Department of Neonatal Medicine, Brest University Hospital, Brest, France.
7
Assistance Publique-Hôpitaux de Paris, Neonatal intensive care unit, Robert Debré children's hospital, Paris, France. olivier.baud@hcuge.ch.
8
Delegation Paris 7, Inserm U1141, University of Paris, Paris, France. olivier.baud@hcuge.ch.
9
Division of Neonatology and Pediatric Intensive Care, Children's University Hospital of Geneva and University of Geneva, Geneva, Switzerland. olivier.baud@hcuge.ch.

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.

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