NCT05537389

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
736

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jan 2023Jun 2026

First Submitted

Initial submission to the registry

September 9, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

3.5 years

First QC Date

September 9, 2022

Last Update Submit

March 26, 2026

Conditions

Newborn ComplicationCatheter Complications

Outcome Measures

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.

    From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months

Secondary Outcomes (1)

  • Frequency of patients with at least one episode of sepsis.

    From date of randomization until the date of hospital discharge or date of death, whichever came first, assessed up to 6 months

Study Arms (2)

Control

NO INTERVENTION

Patients with central venous access (central umbilical venous catheter or epicutaneous cava catheter)

Filter

EXPERIMENTAL

Patients with central venous access and in-line filters (central umbilical venous catheter or epicutaneous cava catheter)

Device: In-line filter

Interventions

In-line filterDEVICE

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.

Filter

Eligibility Criteria

Age1 Hour - 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • All patients admitted to NICU with at least one central venous catheter

You may not qualify if:

  • Patients with peripheral venous catheter, patients with inflammatory episode at the time of enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Città della Salute e della Scienza

Torino, Italia, 10100, Italy

RECRUITING

Related Publications (9)

  • van den Hoogen A, Krediet TG, Uiterwaal CS, Bolenius JF, Gerards LJ, Fleer A. In-line filters in central venous catheters in a neonatal intensive care unit. J Perinat Med. 2006;34(1):71-4. doi: 10.1515/JPM.2006.009.

    PMID: 16489888BACKGROUND

  • Sasse M, Dziuba F, Jack T, Koditz H, Kaussen T, Bertram H, Beerbaum P, Boehne M. In-line Filtration Decreases Systemic Inflammatory Response Syndrome, Renal and Hematologic Dysfunction in Pediatric Cardiac Intensive Care Patients. Pediatr Cardiol. 2015 Aug;36(6):1270-8. doi: 10.1007/s00246-015-1157-x. Epub 2015 Apr 7.

    PMID: 25845941BACKGROUND

  • Virlouvet AL, Pansiot J, Toumazi A, Colella M, Capewell A, Guerriero E, Storme T, Rioualen S, Bourmaud A, Biran V, Baud O. In-line filtration in very preterm neonates: a randomized controlled trial. Sci Rep. 2020 Mar 19;10(1):5003. doi: 10.1038/s41598-020-61815-4.

    PMID: 32193413BACKGROUND

  • Jack T, Boehne M, Brent BE, Hoy L, Koditz H, Wessel A, Sasse M. In-line filtration reduces severe complications and length of stay on pediatric intensive care unit: a prospective, randomized, controlled trial. Intensive Care Med. 2012 Jun;38(6):1008-16. doi: 10.1007/s00134-012-2539-7. Epub 2012 Apr 12.

    PMID: 22527062BACKGROUND

  • Foster JP, Richards R, Showell MG, Jones LJ. Intravenous in-line filters for preventing morbidity and mortality in neonates. Cochrane Database Syst Rev. 2015 Aug 6;2015(8):CD005248. doi: 10.1002/14651858.CD005248.pub3.

    PMID: 26244380BACKGROUND

  • Eschborn S, Weitkamp JH. Procalcitonin versus C-reactive protein: review of kinetics and performance for diagnosis of neonatal sepsis. J Perinatol. 2019 Jul;39(7):893-903. doi: 10.1038/s41372-019-0363-4. Epub 2019 Mar 29.

    PMID: 30926891BACKGROUND

  • van Lingen RA, Baerts W, Marquering AC, Ruijs GJ. The use of in-line intravenous filters in sick newborn infants. Acta Paediatr. 2004 May;93(5):658-62. doi: 10.1111/j.1651-2227.2004.tb02993.x.

    PMID: 15174791BACKGROUND

  • Worthington P, Gura KM, Kraft MD, Nishikawa R, Guenter P, Sacks GS; ASPEN PN Safety Committee. Update on the Use of Filters for Parenteral Nutrition: An ASPEN Position Paper. Nutr Clin Pract. 2021 Feb;36(1):29-39. doi: 10.1002/ncp.10587. Epub 2020 Oct 22.

    PMID: 33091206BACKGROUND

  • Cresi F, Maggiora E, Capetti C, Capitanio M, Ferroglio M, Spada E, De Matteis F, Cosimi S, Mosca F, Coscia A; INCAS Trial Research Group. Effect of in-line filtration in newborns: study protocol of the Intravenous Neonatal Central Access Safety (INCAS) randomized controlled trial. Trials. 2024 Jul 6;25(1):459. doi: 10.1186/s13063-024-08264-w.

    PMID: 38971756DERIVED

Study Officials

  • Francesco Cresi, PhD MD

    University of Turin, Italy

    STUDY DIRECTOR

  • Alessandra Coscia, PhD MD

    University of Turin, Italy

    STUDY DIRECTOR

  • Elena Maggiora, MD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

  • Cecilia Capetti, MD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

  • Francesca De Matteis, RN

    Città della salute e della Scienza di Torino

    PRINCIPAL INVESTIGATOR

  • Martina Capitanio, MD

    University of Turin, Italy

    PRINCIPAL INVESTIGATOR

  • Fabio Mosca, Prof.

    University of Milan, Italy

    STUDY CHAIR

Central Study Contacts

Francesco Cresi, PhD MD

CONTACT

+390113135781incas@cresi.org

Elena Maggiora, MD

CONTACT

+390113134437incas@cresi.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Director

Study Record Dates

First Submitted

September 9, 2022

First Posted

September 13, 2022

Study Start

January 1, 2023

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)