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

NCT03477409 | Unknown

• 2 other identifiers: CHU-3822017-A02073-50
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonates or Premature Babies; Patient With Urinary Catheter; Patient Hospitalized in NICU

Keywords

plasticizers; medical devices; neonates; exposition

Outcome Measures

Primary Outcomes (2)

• 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 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

  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.

  18 months after the beginning of the study

Study Arms (1)

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

Interventions

plasticizers OTHER

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

Neonatal intensive care patients

Eligibility Criteria

• Age: 1 Day - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

minor patient in NICU

You may qualify if:

• hospitalized minor patient in NICU
• 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

You may not qualify if:

• death of the patient
• leaving hospital
• patient becoming anuric (diuresis \<1mL / kg / h for more than 24 hours) under study

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Premature Birth

Interventions

Plasticizers

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses

Study Officials

• Valérie SAUTOU

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

0473751195; placarin@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2018
• First Posted: March 26, 2018
• Study Start: February 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: January 31, 2019
• Last Updated: March 30, 2018

Record last verified: 2018-03

Locations

FR (1)