Exposure of NICU Patients to PVC Plasticizers in At-risk Clinical Situation: Biomonitoring Study From Urinary Samples
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Measurement of urinary levels of DEHT metabolites
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •death of the patient
- •leaving hospital
- •patient becoming anuric (diuresis <1mL / kg / h for more than 24 hours) under study
结局指标
主要结局
Measurement of urinary levels of DEHT metabolites
时间窗: at day 1
The studied metabolites are specific biological markers
Measurement of urinary levels of TOTM metabolites
时间窗: at day 1
The studied metabolites are specific biological markers
次要结局
- 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)