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

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
• Conditions: Neonates or Premature Babies; Patient With Urinary Catheter; Patient Hospitalized in NICU
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand
    • Principal Investigator: Valérie SAUTOU
    • Sub-Investigator: Benoît BOEUF
    • Sub-Investigator: Laurent STORME

Participation Criteria

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of urinary levels of DEHT metabolites	The studied metabolites are specific biological markers	at day 1
Measurement of urinary levels of TOTM metabolites	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	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.	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

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Valérie SAUTOU, University Hospital, Clermont-Ferrand

Study record dates

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: neonates; plasticizers; medical devices; exposition
• 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