Effect of multi-lumen perfusion line on catheter-related bacteremia in premature infants: study protocol for a cluster-randomized crossover trial.
Bacteremia
/ diagnosis
Catheter-Related Infections
/ diagnosis
Catheterization, Central Venous
/ adverse effects
Catheters, Indwelling
/ microbiology
Central Venous Catheters
/ microbiology
Cross Infection
/ diagnosis
Cross-Over Studies
Equipment Design
Female
Gestational Age
Humans
Infant, Extremely Premature
Infant, Newborn
Infusions, Intravenous
Intensive Care Units, Neonatal
Male
Multicenter Studies as Topic
Randomized Controlled Trials as Topic
Risk Assessment
Risk Factors
Time Factors
Treatment Outcome
Catheter-related bacteremia
Central venous catheter
Drug infusion systems
Infusion device
Neonatal intensive care
Premature infants
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
11 Feb 2019
11 Feb 2019
Historique:
received:
19
04
2017
accepted:
21
01
2019
entrez:
13
2
2019
pubmed:
13
2
2019
medline:
14
6
2019
Statut:
epublish
Résumé
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. 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. 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. ClinicalTrials.gov, NCT02633124 . Registered on 7 December 2015.
Sections du résumé
BACKGROUND
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
METHODS
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
CONCLUSIONS
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
BACKGROUND
ClinicalTrials.gov, NCT02633124 . Registered on 7 December 2015.
Identifiants
pubmed: 30744679
doi: 10.1186/s13063-019-3218-6
pii: 10.1186/s13063-019-3218-6
pmc: PMC6371532
doi:
Banques de données
ClinicalTrials.gov
['NCT02633124']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
115Subventions
Organisme : GIRCI Nord-Ouest
ID : AAP Innovation 2014
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