NCT07893522 Understanding the Subnormal Rescue ofNeurological Development in Congenital Hypothyroidism (2022E5SZEM)
| NCT ID | NCT07893522 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Giannina Gaslini |
| Condition | Congenital Hypothyroidism |
| Study Type | OBSERVATIONAL |
| Enrollment | 178 participants |
| Start Date | 2024-06-20 |
| Primary Completion | 2025-12-05 |
Eligibility & Interventions
Eligibility Fast-Check
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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 178 participants in total. It began in 2024-06-20 with a primary completion date of 2025-12-05.
⚠ 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
Congenital hypothyroidism (CH) is a condition present at birth in which the thyroid gland does not produce enough thyroid hormones. These hormones are essential for normal brain development. Although early diagnosis through newborn screening and treatment with thyroid hormone help prevent serious learning difficulties, some children with CH may still experience difficulties with thinking, learning, or development. This study aims to understand why some children with CH do not achieve the expected level of neurological and cognitive development despite early treatment. The researchers will study 39 patients with CH and compare them with 39 similar individuals without the condition. They will also study 50 children with mild neonatal hyperthyrotropinemia (MNH), a condition involving mildly elevated thyroid-stimulating hormone levels, and compare them with 50 children without the condition. The study will assess medical information, growth measurements, and cognitive test results. Genetic testing will be used to identify changes in genes that may affect thyroid function or brain development. The researchers will also examine chemical changes that regulate how genes work, known as epigenetic changes, and analyze blood samples to identify differences in substances involved in the body's metabolism. By combining these findings, the study aims to identify factors associated with less favorable developmental outcomes and potential markers that may help identify children at risk. The results may improve understanding of congenital thyroid disorders and support earlier recognition of children who may need additional assessment or individualized care.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07893522 clinical trial?
This trial is open to participants of all sexes, aged 28 Days or older, 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 NCT07893522 currently recruiting?
Yes, NCT07893522 is actively recruiting participants. Contact the research team at mohamadmaghnie@gaslini.org for enrollment information.
Where is the NCT07893522 trial being conducted?
This trial is being conducted at Genova, Italy, Milan, Italy, Naples, Italy.
Who is sponsoring the NCT07893522 clinical trial?
NCT07893522 is sponsored by Istituto Giannina Gaslini. The trial plans to enroll 178 participants.