Preterm BirthEDELWEISSNCT05058534
Multiperfusion Neonatal System
An observational study of Preterm Birth, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Infusion and parenteral nutrition play an important role in the management of neonatal intensive care patients. Administration of drugs and parenteral nutrition solutions to the patient is performed via different systems including a catheter and a perfusion system. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Birth
- What is being tested?
- Multiline Neo®
- Type of treatment
- Medical device
- How many people
- 640 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2018to 31 Dec 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Infants born between November 30, 2018 and December 31, 2022, at a gestational age below 33 weeks, and hospitalized in the Neonatal unit of Croix-Rousse hospital
Who may be able to join
- Born between November 30, 2018 and December 31, 2022,
- Gestational age below 33 weeks
Who cannot join
- Severe malformation and / or disease requiring heavy surgical management in the neonatal period
- Admitted at croix rousse hospital after the third day of life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a New Multiperfusion Neonatal System on Health and Cost of Care in Neonates
Infusion and parenteral nutrition play an important role in the management of neonatal intensive care patients. Administration of drugs and parenteral nutrition solutions to the patient is performed via different systems including a catheter and a perfusion system. In critically ill, high risk neonates, use of these systems is associated with complications such as infections, interactions between drugs simultaneously infused on the same route (precipitates, catheter obstruction), less effective treatment due to modified amount of drug administered compared to expected or to compatibility issues between drugs. Sepsis and reduction of treatment efficacy can have an impact on survival or subsequent neurodevelopment. Late onset sepsis is one of the most frequent complications in very premature infants born before 33 weeks gestational age and most of those infections occur in infants requiring a perfusion system and an intravenous catheter.
In this context, a new multiperfusion device was developed (Multiline Néo®, Doran, France) to remove access to the infusion system from the incubator where high temperature and humidity favour bacterial growth. But also to allow the administration of several drug solutions simultaneously avoiding contact between drugs.
Our hypothesis is that the new perfusion system helps to reduce the risk of infections, without increase in costs.
- Conditions
- Preterm Birth
- Being tested
- Multiline Neo®
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiline Neo®Device
Multiperfusion neonatal system
| Study group | Role | What they receive |
|---|---|---|
| Very preterm infants born between November 30, 2018 and November 30, 2019 | Infants born between November 30, 2018 - November 30, 2019, before implementation of the new multiperfusion neonatal system | |
| Very preterm infants born between December 1st, 2019 and December 31st, 2022 | Infants born between January 1rst, 2019 - December 31st, 2022, after implementation of the new multiperfusion neonatal system Receives: Device: Multiline Neo® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of infection
Number of infections per 1000 catheter days, per patient during hospital stay
Measured: through study completion, an average of 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Nov 2018
- Primary completion1 Nov 2018
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 640 participants (actual)
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
- NCT05058534
- Sponsor's protocol ID
- CRC_GHN_2021_004
- Acronym
- EDELWEISS
- Status last verified
- Feb 2024
- First submitted
- 14 Sep 2021
- Last updated
- 1 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be shared
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a New Multiperfusion Neonatal System on Health and Cost of Care in Neonates
- ClinicalTrials.gov ID
- NCT05058534
- Acronym / sponsor ID
- EDELWEISS / CRC_GHN_2021_004
- Conditions
- Preterm Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 640 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 27 Sep 2021 (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.
Infusion and parenteral nutrition play an important role in the management of neonatal intensive care patients. Administration of drugs and parenteral nutrition solutions to the patient is performed via different systems including a catheter and a perfusion system. In critically ill, high risk neonates, use of these systems is associated with complications such as infections, interactions between drugs simultaneously infused on the same route (precipitates, catheter obstruction), less effective treatment due to modified amount of drug administered compared to expected or to compatibility issues between drugs. Sepsis and reduction of treatment efficacy can have an impact on survival or subsequent neurodevelopment. Late onset sepsis is one of the most frequent complications in very premature infants born before 33 weeks gestational age and most of those infections occur in infants requiring a perfusion system and an intravenous catheter.
In this context, a new multiperfusion device was developed (Multiline Néo®, Doran, France) to remove access to the infusion system from the incubator where high temperature and humidity favour bacterial growth. But also to allow the administration of several drug solutions simultaneously avoiding contact between drugs.
Our hypothesis is that the new perfusion system helps to reduce the risk of infections, without increase in costs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very preterm infants born between November 30, 2018 and November 30, 2019 | – | –Infants born between November 30, 2018 - November 30, 2019, before implementation of the new multiperfusion neonatal system |
| Very preterm infants born between December 1st, 2019 and December 31st, 2022 | – | Device: Multiline Neo®Infants born between January 1rst, 2019 - December 31st, 2022, after implementation of the new multiperfusion neonatal system |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Infants born between November 30, 2018 and December 31, 2022, at a gestational age below 33 weeks, and hospitalized in the Neonatal unit of Croix-Rousse hospital
Key inclusion criteria (2 listed)
- Born between November 30, 2018 and December 31, 2022,
- Gestational age below 33 weeks
Key exclusion criteria (2 listed)
- Severe malformation and / or disease requiring heavy surgical management in the neonatal period
- Admitted at croix rousse hospital after the third day of life
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 |
|---|---|---|
| Multiline Neo®Multiperfusion neonatal system | Device | Very preterm infants born between December 1st, 2019 and December 31st, 2022 |
Primary outcome
Occurence of infection
Time frame: through study completion, an average of 60 days
Number of infections per 1000 catheter days, per patient during hospital stay
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2024.
- Individual participant dataSharing planned: No. The individual participant data will not be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preterm Birth, run by Hospices Civils de Lyon at 1 site 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 1 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Occurence of infection (time frame: through study completion, an average of 60 days). 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 1 Mar 2024.