Neonatal Screening of Biotinidase Deficiency: Genotype-phenotype Correlation and Clinical Follow-up of Patients Identified At the Regional Centre for Neonatal Screening of Endocrine-Metabolic Diseases in Bologna

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Retro-prospective, single-centre, observational study conducted at the Endocrine-Metabolic Diseases Center of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy. The study involves children born in Emilia-Romagna region, Italy, from January 2016 to December 2020 with biotinidase deficiency identified through Neontal Screening at the Endocrine-Metabolic Diseases Center of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy. The primary aim of this study is to assess the incidence of biotinidase decificiency in this cohort of patients and the possible correlation between the genotype and the biochemical and clinical phenotype of this cohort of patients.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 3
Healthy Volunteers: f
View:

⁃ FOR PEDIATRIC PATIENTS

• Neonatal Screening test result of Residual biotinidase Enzyme Activity \<50% carried out from January 2016 to December 2019 at the Endocrine-Metabolic Diseases Center of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy;

• Obtaining informed consent from parents or legal guardian of pediatric patients.

⁃ FOR PARENTS

• Being a parent of a paediatric patient enrolled in the study;

• Availability of parental data;

• Obtaining informed consent.

Locations
Other Locations
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Contact Information
Primary
Rita Ortolano, MD
rita.ortolano@aosp.bo.it
00390512144816
Time Frame
Start Date: 2021-04-21
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 180
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov

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