Abstract
BackgroundCatheter-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/designThis 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.DiscussionThe 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 registrationClinicalTrials.gov, NCT02633124. Registered on 7 December 2015.
Highlights
Catheter-related bacteremia (CRB) is the most frequent nosocomial infection in neonatal intensive care unit (NICU) patients, especially in very low-birth-weight infants
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
The aim is to study the efficacy of Edelvaiss® Multiline NEO over standard infusion devices in reducing the risk of CRB in preterm newborn infants < 28 ± 6 weeks admitted to an NICU
Summary
It is essential to assess this new multi-lumen device developed and designed for neonates so as to determine its effectiveness in preventing CRB in NICU patients. In preterm and term newborn infants admitted to NICUs, the number of catheter manipulations was significantly different between patients contracting CRB or not (70.7 vs 28.7; p < 0.001) [6]. A recent study found a 77% reduction in CRB rates by implementing evidence-based measures for catheter care in an NICU [16]. The cluster-randomized crossover design ensures good team training in the handling of devices as their use is repeated during each period. As special care must be taken to prevent contamination of blood culture during blood sampling, healthcare providers will have to be trained to comply strictly to the written procedure of evidence-based guidelines on blood culture sampling (Additional file 1).
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