Clinical trial NCT03477409: Exposure of NICU Patients to PVC Plasticizers in At-risk Clinical Situation: Biomonitoring Study From Urinary Samples
Official title: Exposure of NICU Patients to PVC Plasticizers in At-risk Clinical Situation: Biomonitoring Study From Urinary Samples
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neonates or Premature Babies
Patient With Urinary Catheter
Patient Hospitalized in NICU
Keywords: plasticizers
medical devices
neonates
exposition
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 90
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: minor patient in NICU

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.

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

Eligibility 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

Primary outcomes:
measure: Measurement of urinary levels of DEHT metabolites
timeFrame: at day 1
measure: Measurement of urinary levels of TOTM metabolites
timeFrame: at day 1
Secondary outcomes:
measure: Correlation of urinary levels of TOTM and DEHT metabolites to corresponding plasticizers doses released by PVC medical devices to which patients are exposed
timeFrame: 18 months after the beginning of the study
measure: 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.
timeFrame: 18 months after the beginning of the study
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Valérie SAUTOU
role: PRINCIPAL_INVESTIGATOR
References: