Actively Recruiting

Age: 0 - 36Months
All Genders
NCT06723925

Neonatal Screening of Biotinidase Deficiency: Genotype-phenotype Correlation and Clinical Follow-up

Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-03-12

180

Participants Needed

1

Research Sites

297 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Neonatal Screening of Biotinidase Deficiency: Genotype-phenotype Correlation and Clinical Follow-up

Who Can Participate

Age: 0 - 36Months
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Pediatric patients with neonatal screening showing residual biotinidase enzyme activity less than 50% from January 2016 to December 2019 at the Endocrine-Metabolic Diseases Center of the Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Italy
  • Pediatric patients with neonatal screening showing residual biotinidase enzyme activity less than 30% from January 2020 to December 2020 at the same center
  • Informed consent obtained from parents or legal guardians of pediatric patients
  • Parents of enrolled pediatric patients
  • Availability of parental data
  • Informed consent obtained from parents
Not Eligible

You will not qualify if you...

  • Known chromosomal abnormalities or complex syndromes

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, Italy, 40138

Actively Recruiting

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Research Team

R

Rita Ortolano, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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