Neonatal InfectionEDELVAISSNCT06656104
Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream Infections
An observational study of Neonatal Infection, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
The management of premature infants hospitalized in neonatal units requires the simultaneous intravenous (IV) infusion of several drugs and parenteral nutrition solutions, when oral administration is impossible or unsuitable. Read more about this study
- Who is it for?
- Ages Up to 32 weeks
- Conditions the study is for
- Neonatal Infection
- What is being tested?
- Reference strategy and Experimental strategy
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 569 participants
- Where
- 3 sitesFrance
- Study dates
- 14 Jan 2025to 14 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Up to 32 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Infants born at less than 32 weeks and with a birth weight of less than 1600 g, requiring the use of a multi-infusion strategy to administrate several drugs or solutions.
Who may be able to join
- Gestational age at birth ≤ 32 weeks
- Birthweight ≤ 1600 g
- Admitted in the first 3 days of life in the neonatal unit
- Hospitalized in the neonatal unit for at least 1 day
- Survived the first three days of life
- Requires the use of infusion sets for the administration of multiple drugs or solutions, whether or not they have the device in place
- Receipt of the non-opposition from parents or guardians
Who cannot join
- Opposition by parents or guardians
- Lethal or complicated malformation
- Chromosomal anomaly
- Participation of the infant in any other research that may interfere with the results of this study, in the judgment of the investigator
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites, 2 recruiting
- Recruiting
Service de néonatologie Hôpital Femme Mère Enfant
Bron, 69500
Marine BUTIN, Pr, 0427855286, Marine.butin@chu-lyon.fr
Marine BUTIN, Pr
- Not yet recruiting
Service Pédiatrie néonatale et réanimations CHU Montpellier
Montpellier, 34090
Gilles CAMBONIE, Pr, 04 67 33 66 09, g-cambonie@chu-montpellier.fr
Gilles CAMBONIE, Pr
- Active, not recruiting
Service de néonatologie CHU de Strasbourg
Strasbourg, 67091
About this study
The management of premature infants hospitalized in neonatal units requires the simultaneous intravenous (IV) infusion of several drugs and parenteral nutrition solutions, when oral administration is impossible or unsuitable. IV administration requires the use of a central venous catheter and an infusion set that connects the catheter to the infusion fluid or drug. The use of multiple infusion devices exposes patients to central line-associated bloodstream infections (CLABSI), drug interactions, abnormal administration timing and repetition of procedures in close proximity to the infant.
Against this backdrop, DORAN INTERNATIONAL has developed the EDELVAISS multi-infusion strategy (Multiline Neo® and Escape Line® devices) adapted to neonatology. Given its characteristics, the benefits expected from the use of this strategy are: 1) to reduce the risk of microbial contamination and therefore the number of nosocomial infections 2) reduce exposure to antibiotics used in late sepsis 3) reduce the number of central line losses due to catheter obstruction 4) reduce dys-stimulating procedures in contact with the infant and 5) reduce staff stress.
Read more
A pilot study before (year 2019) and after (year 2020) was carried out in the tertiary care neonatal unit at Croix-Rousse hospital. The baseline CLABSI rate was slightly below the national level of the last French survey (12.4/1000 catheter days [95%CI:10.8;14.0]). In 322 very-low-birth-weight infants, the investigators showed a significant 88% reduction in the rate of catheter-related bacteremia, from 11.3 to 2.2 infections per 1,000 catheter-days after implementation of the EDELVAISS multi-infusion strategy.
Since this pilot study, the EDELVAISS multi-infusion strategy has been used routinely in the neonatology department for around 2,000 infants admitted to the neonatology department at Croix-Rousse hospital. The low CLABSI rate observed in 2020 was maintained over the following 2 years. Several tertiary care neonatology departments have implemented the EDELVAISS multi-infusion strategy (ten departments have already done so, and five are in the process of doing so). The three neonatal units that agreed to take part in the EDELVAISS study also wish to implement the EDELVAISS multi-infusion strategy.
The invetsigators hypothesize that the reduction in CLABSI rates observed in the neonatal unit at Croix-Rousse hospital during the pilot study will be found in other French neonatal units, whatever the initial practices and devices used in each center.
- Conditions
- Neonatal Infection
- Being tested
- Reference strategy, Experimental strategy
- Keywords
- neonatal infection, prematurity, catheter, parenteral, perfusion
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference strategyDevice
Routine strategy based on the usual catheters and infusion systems used during the reference period
Experimental strategyDevice
EDELVAISS multi-infusion strategy as routine strategy during the experimental period
| Study group | Role | What they receive |
|---|---|---|
| Reference period | The center used the routine strategy based on the usual catheters and infusion systems (reference strategy). The duration of this period depending to the randomization of the center (i.e. 4 months, 8 months or 12 months) Receives: Device: Reference strategy | |
| Experimental period | At the end of the reference period, center will progressively switch to the new multi-infusion strategy (experimental strategy). The center used the Multiline Neo system to the routine strategy. The duration of this period depending to the randomization of the center (i.e. 12 months, 8 months or 4 months) Receives: Device: Experimental strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of central line associated bloodstream infections (CLABSI) in very preterm infants
The primary endpoint is the number of infections per 1000 catheter-days
Measured: Up to six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start14 Jan 2025
- Primary completion14 Aug 2027 (estimated)
- Study completion14 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 569 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06656104
- Sponsor's protocol ID
- 69HCL23_0812
- Other IDs
- 2024-A00830-47
- Acronym
- EDELVAISS
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2024
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Multi-infusion Strategy in Neonatology on the Rate of Central Line-associated Bloodstream Infections
- ClinicalTrials.gov ID
- NCT06656104
- Acronym / sponsor ID
- EDELVAISS / 69HCL23_0812
- Conditions
- Neonatal Infection
- Keywords
- neonatal infection, prematurity, catheter, parenteral, perfusion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 569 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 14 Aug 2027 (estimated)
- Study completion
- 14 Aug 2027 (estimated)
- First posted
- 24 Oct 2024 (actual)
- 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.
The management of premature infants hospitalized in neonatal units requires the simultaneous intravenous (IV) infusion of several drugs and parenteral nutrition solutions, when oral administration is impossible or unsuitable. IV administration requires the use of a central venous catheter and an infusion set that connects the catheter to the infusion fluid or drug. The use of multiple infusion devices exposes patients to central line-associated bloodstream infections (CLABSI), drug interactions, abnormal administration timing and repetition of procedures in close proximity to the infant.
Against this backdrop, DORAN INTERNATIONAL has developed the EDELVAISS multi-infusion strategy (Multiline Neo® and Escape Line® devices) adapted to neonatology. Given its characteristics, the benefits expected from the use of this strategy are: 1) to reduce the risk of microbial contamination and therefore the number of nosocomial infections 2) reduce exposure to antibiotics used in late sepsis 3) reduce the number of central line losses due to catheter obstruction 4) reduce dys-stimulating procedures in contact with the infant and 5) reduce staff stress.
A pilot study before (year 2019) and after (year 2020) was carried out in the tertiary care neonatal unit at Croix-Rousse hospital. The baseline CLABSI rate was slightly below the national level of the last French survey (12.4/1000 catheter days [95%CI:10.8;14.0]). In 322 very-low-birth-weight infants, the investigators showed a significant 88% reduction in the rate of catheter-related bacteremia, from 11.3 to 2.2 infections per 1,000 catheter-days after implementation of the EDELVAISS multi-infusion strategy.
Since this pilot study, the EDELVAISS multi-infusion strategy has been used routinely in the neonatology department for around 2,000 infants admitted to the neonatology department at Croix-Rousse hospital. The low CLABSI rate observed in 2020 was maintained over the following 2 years. Several tertiary care neonatology departments have implemented the EDELVAISS multi-infusion strategy (ten departments have already done so, and five are in the process of doing so). The three neonatal units that agreed to take part in the EDELVAISS study also wish to implement the EDELVAISS multi-infusion strategy.
The invetsigators hypothesize that the reduction in CLABSI rates observed in the neonatal unit at Croix-Rousse hospital during the pilot study will be found in other French neonatal units, whatever the initial practices and devices used in each center.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reference period | – | Device: Reference strategyThe center used the routine strategy based on the usual catheters and infusion systems (reference strategy). The duration of this period depending to the randomization of the center (i.e. 4 months, 8 months or 12 months) |
| Experimental period | – | Device: Experimental strategyAt the end of the reference period, center will progressively switch to the new multi-infusion strategy (experimental strategy). The center used the Multiline Neo system to the routine strategy. The duration of this period depending to the randomization of the center (i.e. 12 months, 8 months or 4 months) |
Who may qualify
- Ages
- Up to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants born at less than 32 weeks and with a birth weight of less than 1600 g, requiring the use of a multi-infusion strategy to administrate several drugs or solutions.
Key inclusion criteria (7 listed)
- Gestational age at birth ≤ 32 weeks
- Birthweight ≤ 1600 g
- Admitted in the first 3 days of life in the neonatal unit
- Hospitalized in the neonatal unit for at least 1 day
- Survived the first three days of life
Key exclusion criteria (4 listed)
- Opposition by parents or guardians
- Lethal or complicated malformation
- Chromosomal anomaly
- Participation of the infant in any other research that may interfere with the results of this study, in the judgment of the investigator
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 |
|---|---|---|
| Reference strategyRoutine strategy based on the usual catheters and infusion systems used during the reference period | Device | Reference period |
| Experimental strategyEDELVAISS multi-infusion strategy as routine strategy during the experimental period | Device | Experimental period |
Primary outcome
Incidence of central line associated bloodstream infections (CLABSI) in very preterm infants
Time frame: Up to six months
The primary endpoint is the number of infections per 1000 catheter-days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Infection, run by Hospices Civils de Lyon at 3 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 7 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Charles PICAUD, MD, PhD (04 72 00 15 50, jean-charles.picaud@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of central line associated bloodstream infections (CLABSI) in very preterm infants (time frame: Up to six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Oct 2026.