NCT06724224 Comparison of Levothyroxine Formulations in the Treatment of Congenital Hypothyroidism
| NCT ID | NCT06724224 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Congenital Hypothyroidism |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-04-08 |
| Primary Completion | 2031-04-08 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-04-08 with a primary completion date of 2031-04-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Contact & Investigator
Rita Ortolano, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06724224 clinical trial?
This trial is open to participants of all sexes, up to 11 Years, studying Congenital Hypothyroidism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06724224 currently recruiting?
Yes, NCT06724224 is actively recruiting participants. Contact the research team at rita.ortolano@aosp.bo.it for enrollment information.
Where is the NCT06724224 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06724224 clinical trial?
NCT06724224 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Rita Ortolano, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 120 participants.