Understanding brain development in congenital hypothyroidism: comparing affected children, healthy controls, and mild thyroid conditions

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study seeks to understand why some children with congenital hypothyroidism (CH) have poorer neurological and cognitive development despite early treatment. It compares 39 CH patients to 39 matched controls, and 50 children with mild neonatal hyperthyrotropinemia to 50 controls, to identify factors related to development. Researchers will review medical histories, growth data, and cognitive test results to look for patterns. The study is conducted at multiple pediatric centers in Italy and is led by the Istituto Giannina Gaslini, with collaborations across participating institutions. No interventions are being tested; the goal is to learn more about development outcomes in CH and related thyroid conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults and minors with congenital hypothyroidism (CH).
* Family members of patients with CH.
* Healthy controls without thyroid-related conditions or other conditions that could interfere with the study.

Exclusion Criteria:

* Refusal to provide informed consent to participate in the study.
* Intercurrent conditions or severe comorbidities that could interfere with study procedures.

Where it's running

• IRCCS Istituto G. Gaslini
  Genova, Italy Recruiting
• Istituto Auxologico Milano
  Milan, Italy Recruiting
• UOS di Endocrinologia Pediatrica del Dipartimento Assistenziale ad Attivita' Integrata Materno nfantile dell'Azienda Ospedaliera Universitaria Federico II di Napoli
  Naples, Italy Recruiting

Study contacts

• Study coordinator: Mohamad Maghnie, Professor
• Email: mohamadmaghnie@gaslini.org
• Phone: +39 01056362574

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.