Status:
COMPLETED
Clinical and Genetic Analysis in Congenital Hypothyroidism Due to Thyroid Dysgenesis.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
URC-CIC Paris Descartes Necker Cochin
Conditions:
Congenital Hypothyroidism
Eligibility:
All Genders
Phase:
NA
Brief Summary
Congenital hypothyroidism (CH) is a rare disease that affects 1 in 3500 newborn. This condition is detected consistently since the late 1970s in France, which has led to early care and a significant i...
Detailed Description
Congenital hypothyroidism (CH) is a rare disease that affects 1 in 3500 newborn. This condition is detected consistently since the late 1970s in France, which has enabled early care and a significant ...
Eligibility Criteria
Inclusion
- \- Patient: newborn (0-27 days) or infant (28 days 23 months), or child or adult with congenital hypothyroidism (that is to say with a TSH \> 15 mU / ml at screening on filter paper and / or plasma TSH\> 10 mU / ml) diagnosed in the first months of life, whatever their age, sex, weight and size.
- Subjects with blood levels of free thyroid hormones (FT3 and FT4) in the standards will be described as having subclinical hypothyroidism.
- If treatment with L-thyroxine could be stopped without relapse (that is to say, always with a TSH \<5 mU / ml with different controls), hypothyroidism is said to be transient, whatever the age of discontinuation of treatment.
- No pre or neonatal goitre by palpation or ultrasound thyroid
- negative perchlorate test (ie decreased rate of iodine captation \<10% at 2h injection of perchlorate) when the thyroid gland in place
- No self-immunity known to thyroid in children with and / or his mother (defined by a antithyroperoxidase antibodies and / or antithyroglobulin)
- Signature of free and informed consent by the patient or his legal representative
- Affiliation or enjoying a social security system
Exclusion
- Presence of markers antithyroid autoimmunity in children and / or mother (antithyroperoxidase antibodies and / or antithyroglobulin)
- Pre or neonatal goiter on palpation or ultrasound thyroid
- Test positive perchlorate (ie salting rate of iodine\> 10% at 2 injection perchlorate)
- Patients of foreign origin returned to their country will be excluded from the study.
Key Trial Info
Start Date :
September 17 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 17 2017
Estimated Enrollment :
558 Patients enrolled
Trial Details
Trial ID
NCT01916018
Start Date
September 17 2013
End Date
March 17 2017
Last Update
September 8 2025
Active Locations (1)
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1
Pediatric endocrinology gynecology and diabetology, Hôpital Necker Enfants Malades, Assistance Publique - Hôpitaux de Paris , Université Paris Descartes, INSERM unit U 845
Paris, France, 75015