Effect of in-line filtration in newborns: study protocol of the Intravenous Neonatal Central Access Safety (INCAS) randomized controlled trial.
Humans
Infant, Newborn
Filtration
/ instrumentation
Intensive Care Units, Neonatal
Single-Blind Method
Multicenter Studies as Topic
Randomized Controlled Trials as Topic
Infusions, Intravenous
Sepsis
Catheterization, Central Venous
/ adverse effects
Parenteral Nutrition
/ adverse effects
Treatment Outcome
C-Reactive Protein
/ analysis
CVC-complications
Filtration
Infusion therapy
Newborn
Presepsin
Preterm
Randomized controlled trial
Sepsis
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
06 Jul 2024
06 Jul 2024
Historique:
received:
16
11
2023
accepted:
19
06
2024
medline:
7
7
2024
pubmed:
7
7
2024
entrez:
6
7
2024
Statut:
epublish
Résumé
Particulate contamination due to infusion therapy (administration of parenteral nutrition and medications) carries a potential health risk for infants in neonatal intensive care units (NICUs). This particulate consists of metals, drug crystals, glass fragments, or cotton fibers and can be generated by drug packaging, incomplete reconstitution, and chemical incompatibilities. In-line filters have been shown to remove micro-organisms, endotoxin, air, and particles in critically ill adults and older infants, but its benefits in newborn remain to be demonstrated. Moreover, 50% of inflammatory episodes in the setting of NICUs are blood culture-negative. These episodes could be partly related to the presence of particles in the infusion lines. A multicenter randomized single-blind controlled trial was designed. All infants admitted to NICUs for which prolonged infusion therapy is expected will be enrolled in the study and randomized to the Filter or Control arm. All patients will be monitored until discharge, and data will be analyzed according to a "full analysis set." The primary outcome is the frequency of patients with at least one sepsis-like event, defined by any association of suspected sepsis symptoms with a level of c-reactive protein (CRP) > 5 mg/L in a negative-culture contest. The frequency of sepsis, phlebitis, luminal obstruction, and the duration of mechanical ventilation and of catheter days will be evaluated as secondary outcomes. The sample size was calculated at 368 patients per arm. This is the first multicenter randomized control trial that compares in-line filtration of parenteral nutrition and other intravenous drugs to infusion without filters. Sepsis-like events are commonly diagnosed in clinical practice and are more frequent than sepsis in a positive culture contest. The risk of these episodes in the target population is estimated at 30-35%, but this data is not confirmed in the literature. If the use of in-line filters results in a significant decrease in sepsis-like events and/or in any other complications, the use of in-line filters in all intravenous administration systems may be recommended in NICUs. ClinicalTrials.gov, NCT05537389, registered on 12 September 2022 ( https://classic. gov/ct2/show/results/NCT05537389?view=results ).
Sections du résumé
BACKGROUND
BACKGROUND
Particulate contamination due to infusion therapy (administration of parenteral nutrition and medications) carries a potential health risk for infants in neonatal intensive care units (NICUs). This particulate consists of metals, drug crystals, glass fragments, or cotton fibers and can be generated by drug packaging, incomplete reconstitution, and chemical incompatibilities. In-line filters have been shown to remove micro-organisms, endotoxin, air, and particles in critically ill adults and older infants, but its benefits in newborn remain to be demonstrated. Moreover, 50% of inflammatory episodes in the setting of NICUs are blood culture-negative. These episodes could be partly related to the presence of particles in the infusion lines.
METHODS
METHODS
A multicenter randomized single-blind controlled trial was designed. All infants admitted to NICUs for which prolonged infusion therapy is expected will be enrolled in the study and randomized to the Filter or Control arm. All patients will be monitored until discharge, and data will be analyzed according to a "full analysis set." The primary outcome is the frequency of patients with at least one sepsis-like event, defined by any association of suspected sepsis symptoms with a level of c-reactive protein (CRP) > 5 mg/L in a negative-culture contest. The frequency of sepsis, phlebitis, luminal obstruction, and the duration of mechanical ventilation and of catheter days will be evaluated as secondary outcomes. The sample size was calculated at 368 patients per arm.
DISCUSSION
CONCLUSIONS
This is the first multicenter randomized control trial that compares in-line filtration of parenteral nutrition and other intravenous drugs to infusion without filters. Sepsis-like events are commonly diagnosed in clinical practice and are more frequent than sepsis in a positive culture contest. The risk of these episodes in the target population is estimated at 30-35%, but this data is not confirmed in the literature. If the use of in-line filters results in a significant decrease in sepsis-like events and/or in any other complications, the use of in-line filters in all intravenous administration systems may be recommended in NICUs.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov, NCT05537389, registered on 12 September 2022 ( https://classic.
CLINICALTRIALS
RESULTS
gov/ct2/show/results/NCT05537389?view=results ).
Identifiants
pubmed: 38971756
doi: 10.1186/s13063-024-08264-w
pii: 10.1186/s13063-024-08264-w
doi:
Substances chimiques
C-Reactive Protein
9007-41-4
Banques de données
ClinicalTrials.gov
['NCT05537389']
Types de publication
Journal Article
Clinical Trial Protocol
Langues
eng
Sous-ensembles de citation
IM
Pagination
459Investigateurs
Arianna Aceti
(A)
Orsola Amato
(O)
Gina Ancora
(G)
Maria Elisabetta Baldassarre
(ME)
Giovanni Barone
(G)
Cristina Bellan
(C)
Gabriella Borgarello
(G)
Roberto Bottino
(R)
Francesca Campagnoli
(F)
Antonella Capasso
(A)
Maria Grazia Capretti
(MG)
Mauro Carpentieri
(M)
Roberto Cinelli
(R)
Luigi Corvaglia
(L)
Simonetta Costa
(S)
Carlo Dani
(C)
Gabriele D'Amato
(G)
Vito D'Andrea
(V)
Andrea Dotta
(A)
Daniele Farina
(D)
Stefania Ferrari
(S)
Alessandra Foglianese
(A)
Annalisa Fracchiolla
(A)
Elena Gallo
(E)
Stefano Ghirardello
(S)
Nicola Laforgia
(N)
Gianluca Lista
(G)
Mattia Luciano
(M)
Chiara Maddaloni
(C)
Gianfranco Maffei
(G)
Alessandra Maggio
(A)
Luca Maggio
(L)
Marzia Maino
(M)
Giovanna Mangili
(G)
Simona Semeria Mantelli
(SS)
Raffaele Manzari
(R)
Isabella Mondello
(I)
Maria Pia Natale
(MP)
Chiara Peila
(C)
Flavia Petrillo
(F)
Valentina Pivetti
(V)
Federica Pontiggia
(F)
Francesco Raimondi
(F)
Maria Grazia Romitti
(MG)
Andrea Sannia
(A)
Patrizia Savant Levet
(PS)
Immacolata Savarese
(I)
Ferdinando Spagnuolo
(F)
Alessia Varalda
(A)
Paolo Ernesto Villani
(PE)
Gianluca Terrin
(G)
Dario Ummarino
(D)
Giovanni Vento
(G)
Informations de copyright
© 2024. The Author(s).
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