多腔灌注管路对早产儿导管相关菌血症的影响：一项整群随机交叉试验的研究方案

Effect of multi-lumen perfusion line on catheter-related bacteremia in premature infants: study protocol for a cluster-randomized crossover trial.

作者信息

Maiguy-Foinard Aurélie, Décaudin Bertrand, Tourneux Pierre, Guillois Bernard, Blanc Thierry, Galène-Gromez Sophie, Masse Morgane, Odou Pascal, Denies Fannette, Dervaux Benoît, Duhamel Alain, Storme Laurent

机构信息

Faculty of Pharmacy, EA 7365, Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA), University of Lille Nord de France, F-59000, Lille, France.

Department of Pharmacy, University Hospital Center of Lille, CHU Lille, Institut de Pharmacie, F-59000, Lille, France.

出版信息

Trials. 2019 Feb 11;20(1):115. doi: 10.1186/s13063-019-3218-6.

DOI:10.1186/s13063-019-3218-6

PMID:30744679

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6371532/

Abstract

BACKGROUND

Catheter-related bacteremia (CRB) is the most frequent nosocomial infection in neonatal intensive care unit (NICU) patients, especially in very low-birth-weight infants. Administration of injectable drugs in premature newborn infants has many particularities and several types of infusion incidents have been reported. The Edelvaiss® Multiline NEO device is a novel multi-lumen access infusion device adapted to the specificities of infusion in neonatology. This multicenter, randomized, controlled study was therefore designed to determine whether or not Edelvaiss® Multiline NEO reduces the risk of CRB in preterm newborn infants in an NICU.

METHODS/DESIGN: This is a multicenter, randomized, controlled trial, using a cluster-randomized crossover design. Four investigator centers (four clusters) will participate in the study and will be randomized into two groups, corresponding to two different sequences (either the Edelvaiss® Multiline NEO or standard infusion system sequence, then vice versa). A total of 280 patients will be recruited. Infants will be enrolled in the study at the time of placing a single-lumen central venous catheter. Three visits recording specific data are planned in the study protocol. The primary outcome measure is the incidence density (ID) of CRB. For each patient, the total number of catheters and CRB incidents as well as the duration of stay in the NICU will be computed and considered for analysis.

DISCUSSION

The study will provide high-quality evidence to determine whether the Multiline NEO device reduces the risk of CRB in preterm newborns in NICUs or not.

TRIAL REGISTRATION

ClinicalTrials.gov, NCT02633124 . Registered on 7 December 2015.

摘要

背景

导管相关菌血症（CRB）是新生儿重症监护病房（NICU）患者中最常见的医院感染，尤其是极低出生体重儿。早产儿注射用药有许多特殊性，且已报告了几种类型的输液事件。Edelvaiss® Multiline NEO装置是一种新型多腔通路输液装置，适用于新生儿科输液的特殊性。因此，本多中心、随机、对照研究旨在确定Edelvaiss® Multiline NEO是否能降低NICU中早产儿发生CRB的风险。

方法/设计：这是一项多中心、随机、对照试验，采用整群随机交叉设计。四个研究中心（四个整群）将参与研究，并随机分为两组，对应两种不同的顺序（Edelvaiss® Multiline NEO或标准输液系统顺序，然后反之）。共招募280名患者。婴儿将在置入单腔中心静脉导管时纳入研究。研究方案计划进行三次记录特定数据的访视。主要结局指标是CRB的发病密度（ID）。对于每位患者，将计算并考虑导管总数、CRB事件以及在NICU的住院时间以进行分析。