- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03477409
Exposure of NICU Patients to PVC Plasticizers in At-risk Clinical Situation: Biomonitoring Study From Urinary Samples (ARMED NEO)
March 29, 2018 updated by: University Hospital, Clermont-Ferrand
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.
Study Overview
Status
Unknown
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- Recruiting
- CHU Clermont-Ferrand
-
Principal Investigator:
- Valérie SAUTOU
-
Sub-Investigator:
- Benoît BOEUF
-
Sub-Investigator:
- Laurent STORME
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 day to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
minor patient in NICU
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- death of the patient
- leaving hospital
- patient becoming anuric (diuresis <1mL / kg / h for more than 24 hours) under study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measurement of urinary levels of DEHT metabolites
Time Frame: at day 1
|
The studied metabolites are specific biological markers
|
at day 1
|
Measurement of urinary levels of TOTM metabolites
Time Frame: at day 1
|
The studied metabolites are specific biological markers
|
at day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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
|
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
|
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
|
18 months after the beginning of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Valérie SAUTOU, University Hospital, Clermont-Ferrand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Anticipated)
January 31, 2019
Study Completion (Anticipated)
January 31, 2019
Study Registration Dates
First Submitted
February 27, 2018
First Submitted That Met QC Criteria
March 19, 2018
First Posted (Actual)
March 26, 2018
Study Record Updates
Last Update Posted (Actual)
March 30, 2018
Last Update Submitted That Met QC Criteria
March 29, 2018
Last Verified
March 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CHU-382
- 2017-A02073-50 (Other Identifier: 2017-A02073-50)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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