Congenital Hypothyroidism in Children With Eutopic Gland or Thyroid Hemiagenesis: Predictive Factors for Transient vs Permanent Hypothyroidism.

Study Overview
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Brief Summary
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In France, the incidence of congenital hypothyroidism has increased significantly since the newborn screening program was introduced in 1978. The largest increase is seen in children with eutopic thyroid gland. More than one-third of children with eutopic gland have transient hypothyroidism. Clinical practice guidelines recommend to re-evaluate thyroid function in children with eutopic gland around the age of 3 years to determine whether hypothyroidism is transient or permanent. Up until today it is still difficult to determine early on whether hypothyroidism is transient or permanent in children with eutopic gland. Our aim is to identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.

Official Title
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Congenital Hypothyroidism in Children With Eutopic Gland or Thyroid Hemiagenesis: Predictive Factors for Transient vs Permanent Hypothyroidism.

Conditions
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Congenital Hypothyroidism

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with congenital hypothyroidism Eutopic thyroid gland or thyroid hemiagenesis Born between 1996 and 2017 Treated at the Nancy Regional and University Hospital Follow-up of at least 3,5 years. Exclusion Criteria: Polymalformative syndrome Thyroid dysgenesis except for thyroid hemiagenesis

Ages Eligible for Study
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Maximum Age: 42 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transient congenital hypothyroidism<br>- children with congenital hypothyroidism who are no longer treated with Levothyroxine at an age of 3 years and 6 months | |
| Permanent congenital hypothyroidism<br>- children with congenital hypothyroidism who are still treated with Levothyroxine at an age of 3 years and 6 months | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis. |  | 42 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the dose of Levothyroxine between children with transient and permanent congenital hypothyroidism at 6 months, 1 year, 2 years and 3 years follow-up. |  | 6 months, 1 year, 2 years, 3 years | 
| Assess the percentage of children with psychomotor impairment at the age of 3,5 years in both groups. |  | 42 months | 
| Assess how many children have had a hearing evaluation in both groups (excluding the newborn hearing screening). |  | 42 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eutopic thyroid gland, transient hypothyroidism