Actively Recruiting
Comparison of Levothyroxine Formulations in the Treatment of Congenital Hypothyroidism
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2026-03-12
120
Participants Needed
1
Research Sites
391 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Observational, retrospective, prospective, pharmacological, single-centre, non-profit study. The aim is to evaluate, in newborns diagnosed with Congenital Hypothyroidism, the medium- and long-term efficacy and safety of the new formulation of levothyroxine in oral solution, compared to the liquid drop formulation and the tablet formulation. The study will involve male and female patients referred to the Neonatal Screening Centre at the Centre for Endocrine-Metabolic Diseases of the Paediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola, Italy, who tested positive for Congenital Hypothyroidism.
CONDITIONS
Official Title
Comparison of Levothyroxine Formulations in the Treatment of Congenital Hypothyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Positive newborn screening test for Congenital Hypothyroidism
- Born in Emilia-Romagna region, Italy, and undergoing confirmation and therapy at the specified center
- Confirmed diagnosis with levothyroxine replacement started in first month of life at the Center for Endocrine-Metabolic Diseases, Pediatrics Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Age 11 years old or younger
- Informed consent obtained from parents and/or legal guardians and assent from minors when applicable
You will not qualify if you...
- Known chromosomal abnormalities or complex syndromes
- Transferred to another center before completing at least one year of follow-up from therapy start
- Started levothyroxine therapy at another center
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
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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