Neonates or Premature BabiesARMED NEONCT03477409
Exposure of NICU Patients to PVC Plasticizers in At-risk Clinical Situation: Biomonitoring Study From Urinary Samples
An observational study of Neonates or Premature Babies and Patient With Urinary Catheter, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
In response to restrictions related to the use of DEHP as a plasticizer for PVC medical devices (MDs), manufacturers have resorted to alternative plasticizers. These are now integrated into many MDs such as infusion sets, extension lines, extracorporeal circuits, nutrition tubings ... etc. Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Neonates or Premature Babies, Patient With Urinary Catheter, Patient Hospitalized in NICU
- What is being tested?
- plasticizers
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2018to 31 Jan 2019
- 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 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: minor patient in NICU
Who may be able to join
- hospitalized minor patient in NICU
- hospitalized patient in one of the planned services of the study- hospital stay provided for inclusion ≥ 48 hours
- patient with a urinary catheter at the time of inclusion in the study
- patient undergoing during the stay at least 1 of the following medical procedures: enteral nutrition, parenteral nutrition, extra-renal purification, ECMO, transfusion, lipid infusion, plasmapheresis
- patient whose parents have expressed their non-opposition to his participation in the study
Who cannot join
- death of the patient
- leaving hospital
- patient becoming anuric (diuresis <1mL / kg / h for more than 24 hours) under study
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr
Valérie SAUTOU
About this study
In response to restrictions related to the use of DEHP as a plasticizer for PVC medical devices (MDs), manufacturers have resorted to alternative plasticizers. These are now integrated into many MDs such as infusion sets, extension lines, extracorporeal circuits, nutrition tubings ... etc. The ARMED project (2012-2015) funded by the ANSM, whose goal was to prioritizing the risk linked to the migration of these plasticizers from MDs, has shown that TOTM and DEHT present the best benefit / risk ratio due to lower migration and cytotoxicity. Nevertheless, it is important to evaluate the level of exposure of neonatal intensive care patients, due to the multi exposure to MD made of PVC, the frequent use of intravenous route and the vulnerability of this at-risk population to the metabolites of these plasticizers.
Read the detailed description
The purpose of this biomonitoring study consists to evaluate the exposure of newborns and premature babies hospitalized in NICU to these plasticizers (DEHT and TOTM), by qualitative and quantitative measurement of their urinary metabolites
- Being tested
- plasticizers
- Keywords
- plasticizers, medical devices, neonates, exposition
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
plasticizersOther
The purpose of this biomonitoring study consists to evaluate the exposure of newborns and premature babies hospitalized in NICU to these plasticizers (DEHT and TOTM), by qualitative and quantitative measurement of their urinary metabolites
| Study group | Role | What they receive |
|---|---|---|
| Neonatal intensive care patients | The purpose of this biomonitoring study consists to evaluate the exposure of newborns and premature babies hospitalized in NICU to these plasticizers (DEHT and TOTM), by qualitative and quantitative measurement of their urinary metabolites Receives: Other: plasticizers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of urinary levels of DEHT metabolites
The studied metabolites are specific biological markers
Measured: at day 1
Measurement of urinary levels of TOTM metabolites
The studied metabolites are specific biological markers
Measured: at day 1
Secondary outcomes (2)
Correlation of urinary levels of TOTM and DEHT metabolites to corresponding plasticizers doses released by PVC medical devices to which patients are exposed
Quantities of plasticizers (TOTM and DEHT) are measured within each MD to which neonates are exposed in NICU. The release doses of plasticizers are evaluated with mathematical model (built from ex vivo experimentations). The study evaluates whether there is a correlation between the doses of TOTM and the DEHT released by the MD and the metabolites levels found in the urine of exposed patients
Measured: 18 months after the beginning of the study
Comparison of urinary levels of TOTM and DEHT and their metabolites to in vitro cytotoxicity and endocrine disruption and to toxicological data from the literature.
The Armed Neo project include laboratory studies to evaluate the cytotoxicity and endocrine disrupting effects of plasticizers and their metabolites. These studies show the concentrations above which DHT, TOTM and metabolites are toxic. The concentrations obtained in the urines of newborns will be compared to these toxicity threshold values
Measured: 18 months after the beginning of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2018
- Study start1 Feb 2018
- Primary completion31 Jan 2019 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonates or Premature BabiesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Valérie SAUTOU, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03477409
- Sponsor's protocol ID
- CHU-382
- Other IDs
- 2017-A02073-50
- Acronym
- ARMED NEO
- Status last verified
- Mar 2018
- First submitted
- 27 Feb 2018
- Last updated
- 30 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exposure of NICU Patients to PVC Plasticizers in At-risk Clinical Situation: Biomonitoring Study From Urinary Samples
- ClinicalTrials.gov ID
- NCT03477409
- Acronym / sponsor ID
- ARMED NEO / CHU-382
- Keywords
- plasticizers, medical devices, neonates, exposition
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 26 Mar 2018 (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.
In response to restrictions related to the use of DEHP as a plasticizer for PVC medical devices (MDs), manufacturers have resorted to alternative plasticizers. These are now integrated into many MDs such as infusion sets, extension lines, extracorporeal circuits, nutrition tubings ... etc. The ARMED project (2012-2015) funded by the ANSM, whose goal was to prioritizing the risk linked to the migration of these plasticizers from MDs, has shown that TOTM and DEHT present the best benefit / risk ratio due to lower migration and cytotoxicity. Nevertheless, it is important to evaluate the level of exposure of neonatal intensive care patients, due to the multi exposure to MD made of PVC, the frequent use of intravenous route and the vulnerability of this at-risk population to the metabolites of these plasticizers.
Detailed description
The purpose of this biomonitoring study consists to evaluate the exposure of newborns and premature babies hospitalized in NICU to these plasticizers (DEHT and TOTM), by qualitative and quantitative measurement of their urinary metabolites
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonatal intensive care patients | – | Other: plasticizersThe purpose of this biomonitoring study consists to evaluate the exposure of newborns and premature babies hospitalized in NICU to these plasticizers (DEHT and TOTM), by qualitative and quantitative measurement of their urinary metabolites |
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- minor patient in NICU
Key inclusion criteria (5 listed)
- hospitalized minor patient in NICU
- hospitalized patient in one of the planned services of the study- hospital stay provided for inclusion ≥ 48 hours
- patient with a urinary catheter at the time of inclusion in the study
- patient undergoing during the stay at least 1 of the following medical procedures: enteral nutrition, parenteral nutrition, extra-renal purification, ECMO, transfusion, lipid infusion, plasmapheresis
- patient whose parents have expressed their non-opposition to his participation in the study
Key exclusion criteria (3 listed)
- death of the patient
- leaving hospital
- patient becoming anuric (diuresis <1mL / kg / h for more than 24 hours) under study
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 |
|---|---|---|
| plasticizersThe purpose of this biomonitoring study consists to evaluate the exposure of newborns and premature babies hospitalized in NICU to these plasticizers (DEHT and TOTM), by qualitative and quantitative measurement of their urinary metabolites | Other | Neonatal intensive care patients |
Primary outcome
Measurement of urinary levels of DEHT metabolites
Time frame: at day 1
The studied metabolites are specific biological markers
Measurement of urinary levels of TOTM metabolites
Time frame: at day 1
The studied metabolites are specific biological markers
2 secondary outcomes
Correlation of urinary levels of TOTM and DEHT metabolites to corresponding plasticizers doses released by PVC medical devices to which patients are exposed
Time frame: 18 months after the beginning of the study
Comparison of urinary levels of TOTM and DEHT and their metabolites to in vitro cytotoxicity and endocrine disruption and to toxicological data from the literature.
Time frame: 18 months after the beginning of the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2018.
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Neonates and Preterm Infants, Neonates or Premature Babies
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.
Valérie SAUTOU principal investigator
University Hospital, Clermont-Ferrand
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 Neonates or Premature Babies and Patient With Urinary Catheter, run by University Hospital, Clermont-Ferrand 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 30 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of urinary levels of DEHT metabolites (time frame: at day 1). The study lists 2 primary outcomes in all. 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 30 Mar 2018; AzTrials last refreshed its copy on 8 Nov 2026.