Intravenous Neonatal Central Access Safety Trial

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.

Conditions

• Newborn Complication
• Catheter Complications

Interventions

DEVICE

In-line filter

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.

Sponsors & Collaborators

• Pall Corporation

  collaborator OTHER

• University of Turin, Italy

  lead OTHER

Principal Investigators

• Francesco Cresi, PhD MD · University of Turin, Italy

• Alessandra Coscia, PhD MD · University of Turin, Italy

• Elena Maggiora, MD · University of Turin, Italy

• Cecilia Capetti, MD · University of Turin, Italy

• Francesca De Matteis, RN · Città della salute e della Scienza di Torino

• Martina Capitanio, MD · University of Turin, Italy

• Fabio Mosca, Prof. · University of Milan, Italy

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Hour

Max Age

3 Months

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-01-01

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Italy

Study Locations