Evaluating Different Levothyroxine Forms for Treating Congenital Hypothyroidism in Children Up to 11 Years Old A Study at the Bologna Neonatal Screening and Endocrine Center

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.

Comparison of Levothyroxine Formulations in the Treatment of Congenital Hypothyroidism