Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.

NCT02633124 | Terminated

• 2 other identifiers: 2014_672015-A00585-44
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 4

Brief Summary

This study evaluates the potential interest of a new multi-lumen infusion access device (Edelvaiss® Multiline NEO) in the prevention of catheter-related bacteremia when administering injectable drugs in premature infants. This device will be compared to the standard infusion set of each center.

Conditions

Bacteremia; Infant, Very Low Birth Weight

Keywords

Premature infants; Catheter-related bacteremia; Infusion device; Neonatal intensive care; Central Venous Catheter; Drug Infusion Systems

Outcome Measures

Primary Outcomes (1)

• Measure of incidence density (ID) of catheter-related bacteremia (CRB)

  Catheter-related bacteremia (CRB) are the most frequent nosocomial infections in Neonatal Intensive Care Unit (NICU) patients. Nosocomial CRB in the NICU contribute significantly to hospital morbidity as well as to increased costs due to prolonged hospitalization. The main objective is to assess the interest of the Multiline NEO in preventing CRB when administering injectable medications in NICU patients. It is whether the Multiline NEO device reduces the risk of CRB in premature infants hospitalized in NICU. Measure of ID of CRB as criteria of Neocat Network during central venous catheterization in the patient.

  Through an average of 30 days

Secondary Outcomes (7)

• Measure of ID of occlusion of components of the infusion system

  Through an average of 30 days

• Number of septic shock

  Through an average of 30 days

• Total duration of oxygen therapy

  Through an average of 30 days

• Total duration of mechanical ventilation

  Through an average of 30 days

• Total duration of parenteral nutrition

  Through an average of 30 days

Study Arms (2)

Edelvaiss Multiline NEO

EXPERIMENTAL

The Edelvaiss Multiline NEO design allows to position the access to the infusion line outside of the incubator, without increasing the residual volume and this device has been validated by the manufacturer as part of CE marking for a period of 21 days.

Device: Edelvaiss Multiline NEO

Standard Infusion Set

OTHER

The infusion set used for the standard group is the infusion set usually used.

Device: Standard Infusion Set

Interventions

Edelvaiss Multiline NEO DEVICE

Use of Edelvaiss Multiline NEO to infuse the parenteral nutrition and drugs during the study period

Edelvaiss Multiline NEO

Standard Infusion Set DEVICE

Use of Standard Infusion Set to infuse the parenteral nutrition and drugs during the study period

Standard Infusion Set

Eligibility Criteria

• Age: 24 Weeks - 29 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Infants with gestational ages between 24 and 29 weeks.
• Infants carrying a single-lumen central venous catheter.
• Obtaining the informed parental consent.

You may not qualify if:

• Infants carrying a multi-lumen central venous catheter.
• Infants carrying a umbilical venous catheter.
• Infants carrying two central venous catheters.
• Refusal of informed parental consent.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Ministry of Health, France: collaborator

Study Sites (4)

Chu Amiens Picardie

Amiens, France

Location

Hôpital Côte de Nacre - CHU de Caen

Caen, France

Location

Hôpital Jeanne de Flandre - CHRU de Lille

Lille, France

Location

Hôpital Charles Nicolle - CHU de Rouen

Rouen, France

Location

Related Publications (3)

• Maiguy-Foinard A, Decaudin B, Tourneux P, Guillois B, Blanc T, Galene-Gromez S, Masse M, Odou P, Denies F, Dervaux B, Duhamel A, Storme L. Effect of multi-lumen perfusion line on catheter-related bacteremia in premature infants: study protocol for a cluster-randomized crossover trial. Trials. 2019 Feb 11;20(1):115. doi: 10.1186/s13063-019-3218-6.

  PMID: 30744679 BACKGROUND

• Mahieu LM, De Dooy JJ, Lenaerts AE, Ieven MM, De Muynck AO. Catheter manipulations and the risk of catheter-associated bloodstream infection in neonatal intensive care unit patients. J Hosp Infect. 2001 May;48(1):20-6. doi: 10.1053/jhin.2000.0930.

  PMID: 11358467 RESULT

• Erdei C, McAvoy LL, Gupta M, Pereira S, McGowan EC. Is zero central line-associated bloodstream infection rate sustainable? A 5-year perspective. Pediatrics. 2015 Jun;135(6):e1485-93. doi: 10.1542/peds.2014-2523. Epub 2015 May 18.

  PMID: 25986020 RESULT

Related Links

• Website of the Multiline NEO manufacturer (Doran International)

MeSH Terms

Conditions

Bacteremia; Premature Birth

Condition Hierarchy (Ancestors)

Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Laurent Storme, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 17, 2015
• Study Start: January 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: April 22, 2026

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4)