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
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the medium- and long-term effectiveness and safety of different levothyroxine formulations in newborns diagnosed with Congenital Hypothyroidism. The study compares a new oral solution form of levothyroxine with existing liquid drop and tablet forms. It includes both retrospective and prospective groups of patients diagnosed through neonatal screening at a specialized center in Italy. Participants are divided into three pharmacological groups based on the levothyroxine formulation they use in routine care: drops, oral solution, or tablets. The prospective cohort includes patients observed from the study approval date over approximately four years, while the retrospective cohort involves children born from 2019 onward who have already received treatment. Clinical, biochemical, radiological, and neurocognitive data are collected and analyzed according to set timelines. Throughout the study, researchers monitor thyroid hormone levels (TSH and FT4) at multiple intervals up to three years after therapy starts. Neuromotor and neurocognitive development is evaluated between one and three years of age. They also track any adverse effects during these follow-ups. The study involves gathering medical history, clinical assessments, laboratory tests, and long-term follow-up to understand how each levothyroxine formulation performs over time.
CONDITIONS
Brief 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
- Diagnosis confirmed and started levothyroxine replacement therapy within the first month of life at the specified center
- Age 11 years or younger
- Informed consent obtained from parents or legal guardians and assent from minors
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 after starting therapy
- Started therapy at a different center
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years after the start of therapy
Participants who undergo routine care are observed with collection of medical history, clinical, biochemical, and radiological data at diagnosis and during follow-up.
Visits at 7-15 days, 1, 3, 6, 12 months, and annually thereafter up to 3 years
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
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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