BacteremiaMultilineNEONCT02633124
Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants.
A study testing Edelvaiss Multiline NEO and Standard Infusion Set in people with Bacteremia and Infant, Very Low Birth Weight, run by University Hospital, Lille at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 24 to 29 weeksHealthy volunteers can take part
- Conditions the study is for
- Bacteremia, Infant, Very Low Birth Weight
- What is being tested?
- Edelvaiss Multiline NEO and Standard Infusion Set
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 4 sitesFrance
- Study dates
- Jan 2016to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 29 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants with gestational ages between 24 and 29 weeks.
- Infants carrying a single-lumen central venous catheter.
- Obtaining the informed parental consent.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites
Chu Amiens Picardie
Amiens
Hôpital Côte de Nacre - CHU de Caen
Caen
Hôpital Jeanne de Flandre - CHRU de Lille
Lille
Hôpital Charles Nicolle - CHU de Rouen
Rouen
About this study
Official title: Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants: Randomized Controlled Multicenter Study of Edelvaiss Multiline NEO Device
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.
Read the detailed description
Edelvaiss® Multiline NEO is a multi-lumen infusion access device, adapted to the neonatal population. It has five ports connected to five lumens separated in a single tube of 90 cm, combined with a small single tube called annex port. Four ports numbered 1 to 4 are connected to four peripheral lumens (residual volume per lumen: 0.6 mL). The fifth port, called central access (indicated by the HF icon (High Flow)), is reserved to the administration of parenteral nutrition. It is connected to the central lumen (residual volume: 4.5 mL). The sixth port on the annex way allows an administration closer to the infant (residual volume: 0.40 mL). It is thus reserved for emergencies and direct intravenous injections.
The innovative technological design of Edelvaiss® Multiline NEO device should enable secure administration of injectable drugs by preventing variations in drug mass flow rate and the occurrence of drug incompatibilities. This device would reduce the number of perfusion incidents and therefore, the frequency of manipulations of infusion lines within the incubator, direct source of occurrence of bacteremia.
Moreover, its main interest lies in neonatology in the possibility of being positioned outside of the incubator and to have a lifetime of 21 days, contributing to the prevention of catheter-related bacteremia. All manipulations are therefore made outside the incubator at the room temperature and the relative humidity, and at a distance from the device/catheter junction.
- Conditions
- Bacteremia, Infant, Very Low Birth Weight
- Being tested
- Edelvaiss Multiline NEO, Standard Infusion Set
- Keywords
- Premature infants, Catheter-related bacteremia, Infusion device, Neonatal intensive care, Central Venous Catheter, Drug Infusion Systems
- Medical subject headings
- Bacteremia, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Edelvaiss Multiline NEODevice
Use of Edelvaiss Multiline NEO to infuse the parenteral nutrition and drugs during the study period
Standard Infusion SetDevice
Use of Standard Infusion Set to infuse the parenteral nutrition and drugs during the study period
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Edelvaiss Multiline NEO |
| Standard Infusion Set | Other | The infusion set used for the standard group is the infusion set usually used. Receives: Device: Standard Infusion Set |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through an average of 30 days
Secondary outcomes (7)
Measure of ID of occlusion of components of the infusion system
Measure of ID of occlusion of components of the infusion system is determined on the period of central venous catheterization in the patient.
Measured: Through an average of 30 days
Number of septic shock
The number of septic shock defined by the use of vasoactive drugs during central venous catheterization in the patient.
Measured: Through an average of 30 days
Total duration of oxygen therapy
Total duration of oxygen therapy is determined from the inclusion of the patient in the study until the end of his hospitalization.
Measured: Through an average of 30 days
Total duration of mechanical ventilation
Total duration of mechanical ventilation is determined from the inclusion of the patient in the study until the end of his hospitalization.
Measured: Through an average of 30 days
Total duration of parenteral nutrition
Total duration of parenteral nutrition is determined from the inclusion of the patient in the study until the end of his hospitalization.
Measured: Through an average of 30 days
Number of bronchopulmonary dysplasia
Number of bronchopulmonary dysplasia defined by the Walsh test is determined from the inclusion of the patient in the study until the end of his hospitalization.
Measured: Through an average of 30 days
Cost of care for patients
Cost of care for patients includes :
- cost of components of the infusion lines, including their replacement,
- cost of nursing time dedicated to handling lines,
- cost of identifying a CRB,
- cost of hospital stay. Cost of care for a patient is calculated from the inclusion of the patient in the study until the end of his hospitalization.
Measured: Through an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionMay 2020
- Study completionMay 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Laurent Storme, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633124
- Sponsor's protocol ID
- 2014_67
- Other IDs
- 2015-A00585-44
- Acronym
- MultilineNEO
- Status last verified
- Nov 2020
- First submitted
- 7 Dec 2015
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30744679Mahieu 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.
PubMed 11358467Erdei 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.
PubMed 25986020
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants: Randomized Controlled Multicenter Study of Edelvaiss Multiline NEO Device
- ClinicalTrials.gov ID
- NCT02633124
- Acronym / sponsor ID
- MultilineNEO / 2014_67
- Conditions
- Bacteremia, Infant, Very Low Birth Weight
- Keywords
- Premature infants, Catheter-related bacteremia, Infusion device, Neonatal intensive care, Central Venous Catheter, Drug Infusion Systems
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- Jan 2016 (actual)
- Primary completion
- May 2020 (actual)
- Study completion
- May 2020 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Edelvaiss® Multiline NEO is a multi-lumen infusion access device, adapted to the neonatal population. It has five ports connected to five lumens separated in a single tube of 90 cm, combined with a small single tube called annex port. Four ports numbered 1 to 4 are connected to four peripheral lumens (residual volume per lumen: 0.6 mL). The fifth port, called central access (indicated by the HF icon (High Flow)), is reserved to the administration of parenteral nutrition. It is connected to the central lumen (residual volume: 4.5 mL). The sixth port on the annex way allows an administration closer to the infant (residual volume: 0.40 mL). It is thus reserved for emergencies and direct intravenous injections.
The innovative technological design of Edelvaiss® Multiline NEO device should enable secure administration of injectable drugs by preventing variations in drug mass flow rate and the occurrence of drug incompatibilities. This device would reduce the number of perfusion incidents and therefore, the frequency of manipulations of infusion lines within the incubator, direct source of occurrence of bacteremia.
Moreover, its main interest lies in neonatology in the possibility of being positioned outside of the incubator and to have a lifetime of 21 days, contributing to the prevention of catheter-related bacteremia. All manipulations are therefore made outside the incubator at the room temperature and the relative humidity, and at a distance from the device/catheter junction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edelvaiss Multiline NEO | Experimental | Device: Edelvaiss Multiline NEOThe 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. |
| Standard Infusion Set | Other | Device: Standard Infusion SetThe infusion set used for the standard group is the infusion set usually used. |
Who may qualify
- Ages
- 24 to 29 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants with gestational ages between 24 and 29 weeks.
- Infants carrying a single-lumen central venous catheter.
- Obtaining the informed parental consent.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Edelvaiss Multiline NEOUse of Edelvaiss Multiline NEO to infuse the parenteral nutrition and drugs during the study period | Device | Edelvaiss Multiline NEO |
| Standard Infusion SetUse of Standard Infusion Set to infuse the parenteral nutrition and drugs during the study period | Device | Standard Infusion Set |
Primary outcome
Measure of incidence density (ID) of catheter-related bacteremia (CRB)
Time frame: Through an average of 30 days
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.
7 secondary outcomes
Measure of ID of occlusion of components of the infusion system
Time frame: Through an average of 30 days
Number of septic shock
Time frame: Through an average of 30 days
Total duration of oxygen therapy
Time frame: Through an average of 30 days
Total duration of mechanical ventilation
Time frame: Through an average of 30 days
Total duration of parenteral nutrition
Time frame: Through an average of 30 days
Number of bronchopulmonary dysplasia
Time frame: Through an average of 30 days
Cost of care for patients
Time frame: Through an average of 30 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 30744679Maiguy-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.
- Results publication: PubMed 11358467Mahieu 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.
- Results publication: PubMed 25986020Erdei 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.
- Website of the Multiline NEO manufacturer (Doran International)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Storme, MD, PhD principal investigator
University Hospital, Lille
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Edelvaiss Multiline NEO and Standard Infusion Set in people with Bacteremia and Infant, Very Low Birth Weight, run by University Hospital, Lille at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of incidence density (ID) of catheter-related bacteremia (CRB) (time frame: Through an average of 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02633124, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.