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

University Hospital, Clermont-Ferrand

Status: Unknown

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

Treatments: Other: plasticizers

Study type: Observational

Funder types: Other

Identifiers

NCT03477409

CHU-382

2017-A02073-50 (Other Identifier)

Details and patient eligibility

About

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.

Full 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

Enrollment: 90 estimated patients

Sex: All

Ages: 1 day to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

90 participants in 1 patient group

Neonatal intensive care patients

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

Treatment:

Other: plasticizers