Intravenous Neonatal Central Access Safety Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-3
SponsorUniversity of Turin, Italy
About this trial
Particulate contamination due to infusion therapy (administration of parenteral nutrition and medications) carries a potential health risk for infants in neonatal intensive care units (NICU).
In-line filtration is increasingly used in critically-ill infants but its benefits, by preventing micro-particle infusion in neonates, remain to be demonstrated.
In-line filters in the intravenous administration sets prevent the infusion of particles, which may reduce infectious complications.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All patients admitted to NICU with at least one central venous catheter
Disqualifiers
Patients with peripheral venous catheter, patients with inflammatory episode at the time of enrollment
Trial design
Design model
Parallel
Treatments tested in this trial
In-line filter
DeviceAll infusions, with the exception of some solutions (eg blood products), will be subjected to filtration. The aqueous solutions (parenteral therapy and drugs) will be administered through 0.2 μm filters which will be replaced every 96 h; the lipid emulsions will be administered through 1.2 μm filters which will be replaced every 24 h. In case of emergency, life-saving drugs will be administered with bolus modality though the infusion line closer to the patient without the need for filtration. In case of drugs/solutions not supported by filtration (eg blood products), they will be administered through a dedicated unfiltered access, which will be removed as soon as the drug is no longer needed.
Treatment groups
736 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: FilterExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Frequency of patients with at least one inflammatory episode sepsis-like.
Frequency of patients with at least one inflammatory episode sepsis-like, defined by alteration of the biomarkers of inflammation in a negative-culture contest.
Time frame
From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 monthsSecondary outcomes
1
Frequency of patients with at least one episode of sepsis.
Frequency of patients with at least one inflammatory episode defined by alteration of the biomarkers of inflammation in a positive-culture contest.
Time frame
From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Turin, Italy
Lead sponsor
Pall Corporation
Collaborator
Source ClinicalTrials.gov