Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®)

NCT05894122 — Unknown, 40 participants, University Hospital, Grenoble

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

Registry	NCT05894122, acronym MitrAlanine
Status	Unknown
Study type	Observational
Enrollment	40 (Estimated)
Sponsor	University Hospital, Grenoble (Other)
Conditions	Phenylketonuria, Metabolic Diseases
Interventions	DM-DIV MITRA® (Diagnostic test)
Dates	start 2023-12-13, primary completion 2025-12-12 (estimated), completion 2025-12-12 (estimated), first posted 2023-06-08, last updated 2023-12-22
Locations	1 site in France

-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.

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+Arms and interventions

DM-DIV MITRA® (Diagnostic test), also known as DM-DIV HemaPEN®: Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).

+Outcome measures

Primary outcomes

Comparison of phenylalanine concentrations [Day 1]: Comparison of phenylalanine concentrations in the new device with those in the current device (blotter).

Secondary outcomes

Ease of use of research device [Day 1]: ease of use of DM-DIV MITRA® and DM-DIV HemaPEN® via a 3 questions-and-answer guide for samplers
sample conformity [Day 1]: Conformity of blood sample on DM-DIV MITRA® and DM-DIV HemaPEN® versus DM-DIV Perkin Elmer
comparison of concentrations of tyrosin [Day 1]: comparison of concentrations of other amino acids (tyrosin) dosed at the same time as phenylalanine
comparison of concentrations of total leucin [Day 1]: comparison of concentrations of other amino acids (total leucin) dosed at the same time as phenylalanine
comparison of concentrations of methionin [Day 1]: comparison of concentrations of other amino acids (methionin) dosed at the same time as phenylalanine

+Eligibility

Sex: All, ages: 3 Months to 18 Years

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.

Exclusion Criteria:

* Parents or legal guardians opposed to the MitrAlanine study

+Locations (1)

Facility	City	Country	Status
CHU Grenoble Alpes	Grenoble	France	Recruiting