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Exposure of NICU Patients to PVC Plasticizers in At-risk Clinical Situation: Biomonitoring Study From Urinary Samples (ARMED NEO)

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ClinicalTrials.gov Identifier: NCT03477409
Recruitment Status : Unknown
Verified March 2018 by University Hospital, Clermont-Ferrand.
Recruitment status was:  Recruiting
First Posted : March 26, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment
Neonates or Premature Babies Patient With Urinary Catheter Patient Hospitalized in NICU Other: 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
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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Exposure of NICU Patients to PVC Plasticizers in At-risk Clinical Situation: Biomonitoring Study From Urinary Samples
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019
Groups and Cohorts
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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
 Other: plasticizers
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


Outcome Measures
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Primary Outcome Measures :
  1. Measurement of urinary levels of DEHT metabolites [ Time Frame: at day 1 ]
    The studied metabolites are specific biological markers

  2. Measurement of urinary levels of TOTM metabolites [ Time Frame: at day 1 ]
    The studied metabolites are specific biological markers


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
minor patient in NICU
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03477409


Contacts
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Contact: Patrick LACARIN 0473751195 placarin@chu-clermontferrand.fr

Locations
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France
CHU Clermont-Ferrand Recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    0473751195    placarin@chu-clermontferrand.fr   
Principal Investigator: Valérie SAUTOU         
Sub-Investigator: Benoît BOEUF         
Sub-Investigator: Laurent STORME         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Valérie SAUTOU University Hospital, Clermont-Ferrand
More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03477409    
Other Study ID Numbers: CHU-382
2017-A02073-50 ( Other Identifier: 2017-A02073-50 )
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
plasticizers
medical devices
neonates
exposition