Taking people in ItalyNo phase
Comparison of Levothyroxine Formulations in the Treatment of Congenital Hypothyroidism
Key facts
- Who runs it
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Where
- Bologna, ItalySee the site
- Trial code
- Status
- Recruiting
- People taking part
- 120 people, planned
- Started
- 8 Apr 2024
- Expected to end
- 8 Oct 2031
- Type of study
- Observational
- Record updated
- 12 March 2026
Who can take part
- Age
- Up to 11 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 2 criteriaShow less
Who can take part
- Newborn screening test positivity for Congenital Hypothyroidism; Subjects born in Emilia-Romagna region, Italy, and undergoing diagnostic confirmation and initiation of replacement therapy; Diagnosis-confirmed subjects who underwent L-T4 replacement therapy in the first month of life at Center for Endocrine-Metabolic Diseases, Pediatrics Units of the IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S.Orsola, Italy; Age ≤11 years old; Obtaining informed consent from parents and/or legal guardians and assent from minors included in the study
Who cannot take part
- Known chromosomal abnormalities or complex syndromes; Patients transferred to another center before completion of at least one year of follow-up from the start of therapy; Patients who started therapy at another center
Where in Italy
- IRCCS Azienda Ospedaliero-Universitaria di BolognaBologna, ItalyContact: Rita Ortolano, MDTaking people
About the trial
What the trial wants to find out
Observational, retrospective, prospective, pharmacological, single-centre, non-profit study.
Read full original descriptionShow less
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.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 12 March 2026