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

NCT02633124 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2026-04-22

No results posted yet for this study

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

Interventions

DEVICE

Edelvaiss Multiline NEO

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

DEVICE

Standard Infusion Set

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

Sponsors & Collaborators

  • Ministry of Health, France

    collaborator OTHER_GOV

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Laurent Storme, MD, PhD · University Hospital, Lille

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
24 Weeks
Max Age
29 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02633124 on ClinicalTrials.gov