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

• Conditions: Congenital Hypothyroidism

• Registration Number: NCT04712760
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-15
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-21
• Study Start: 2021-02-22
• Last Update Posted: 2021-02-23
• Primary Completion: 2021-03-01
• Study Completion: 2021-04-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.	42 months

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Nancy, France