Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®) in the Context of Metabolic Diseases and, in Particular, Pediatric Monitoring of Phenylketonuria

University Hospital, Grenoble1 site in 1 country40 target enrollmentDecember 13, 2023

ConditionsPhenylketonuria Metabolic Diseases

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Phenylketonuria
Sponsor: University Hospital, Grenoble
Enrollment: 40
Locations: 1
Primary Endpoint: Comparison of phenylalanine concentrations
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim is to demonstrate a new application for a blood collection device. This device is already widely used in pharmacology. It is not currently used for metabolic diseases.

Its ease of use enables repeated sampling at home. What's more, the device can be sent by post, making it ideally suited to the needs of this cohort of children, whose phenylalanine levels need to be monitored very regularly.

Registry

clinicaltrials.gov

Start Date

December 13, 2023

End Date

December 12, 2025

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

University Hospital, Grenoble

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Children aged 3 months to 18 years
•suffering from phenylketonuria or hyperphenylalaninemia
•who have had a capillary and blood test including a phenylalanine assay at CHUGA
•Whose parents or legal guardians are affiliated to the social security system.
•For whom parents or legal guardians have not objected to the MitrAlanine study.