Comparison of Levothyroxine Formulations in the Treatment of Congenital Hypothyroidism

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

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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 11
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna
RECRUITING
Bologna
Contact Information
Primary
Rita Ortolano, MD
rita.ortolano@aosp.bo.it
0512144816
Time Frame
Start Date: 2024-04-08
Estimated Completion Date: 2031-10-08
Participants
Target number of participants: 120
Sponsors
Leads: IRCCS Azienda Ospedaliero-Universitaria di Bologna

This content was sourced from clinicaltrials.gov