NCT03477409

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 90 (estimated)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 1 Day – 18 Years
• Healthy volunteers: Not accepted

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.

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

Conditions

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-01-31
• Completion: 2019-01-31
• First posted: 2018-03-26
• Last updated: 2018-03-30

Locations

1 site across 1 country: France