Intravenous Neonatal Central Access Safety Trial
Central Lines Filtration in Newborns: a Multicenter Randomized Controlled Trial
University of Turin, Italy
736 participants
Jan 1, 2023
INTERVENTIONAL
Conditions
Summary
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
Plain Language Summary
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Interventions
All 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.
Locations(1)
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NCT05537389