Evaluating blood collection devices for monitoring phenylketonuria in children
Evaluation of Capillary Blood Collection Devices (Mitra® and HemaPEN®) in the Context of Metabolic Diseases and, in Particular, Pediatric Monitoring of Phenylketonuria
This study is testing two easy-to-use blood collection devices to see if they can help children with phenylketonuria check their phenylalanine levels at home.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 3 Months to 18 Years |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT05894122 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of capillary blood collection devices, specifically Mitra® and HemaPEN®, for monitoring phenylalanine levels in children with phenylketonuria and hyperphenylalaninemia. The devices are designed for ease of use, allowing for repeated blood sampling at home and the ability to send samples by post. This approach is particularly beneficial for children who require regular monitoring of their metabolic condition. The study will involve children aged 3 months to 18 years who have previously undergone blood testing at the participating hospital.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 3 months to 18 years diagnosed with phenylketonuria or hyperphenylalaninemia.
Not a fit: Patients whose parents or legal guardians oppose participation in the MitrAlanine study may not receive any benefit.
Why it matters
Potential benefit: If successful, this study could provide a more convenient and efficient method for monitoring phenylalanine levels in children with metabolic diseases.
How similar studies have performed: While this approach is innovative for metabolic diseases, similar blood collection devices have shown success in pharmacological applications.
Eligibility criteria
Show full inclusion / exclusion 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. Exclusion Criteria: * Parents or legal guardians opposed to the MitrAlanine study
Where this trial is running
Grenoble
- CHU Grenoble Alpes — Grenoble, France (Recruiting)
Study contacts
- Study coordinator: Christelle CORNE, MD
- Email: CCorne@chu-grenoble.fr
- Phone: 04 76 76 92 32
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.