Status:
UNKNOWN
Exposure of NICU Patients to PVC Plasticizers in At-risk Clinical Situation: Biomonitoring Study From Urinary Samples
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Neonates or Premature Babies
Patient With Urinary Catheter
Eligibility:
All Genders
1-18 years
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 s...
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 m...
Eligibility Criteria
Inclusion
- 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
- death of the patient
- leaving hospital
- patient becoming anuric (diuresis \<1mL / kg / h for more than 24 hours) under study
Key Trial Info
Start Date :
February 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 31 2019
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03477409
Start Date
February 1 2018
End Date
January 31 2019
Last Update
March 30 2018
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63003