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

Congenital Hypothyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04712760
• Other study ID #: 2020PI260
• Status: Recruiting
• Start date: February 22, 2021
• Est. completion date: April 1, 2021

Study information

• Verified date: February 2021
• Source: Central Hospital, Nancy, France
• Contact: Emeline Renard, MD
• Phone: +33 3 83 15 45 00
• Email: e.renard[@]chru-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 1, 2021
• Est. primary completion date: March 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 42 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Hypothyroidism
• Hypothyroidism

Locations

Country	Name	City	State
France	CHRU Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.		42 months
Secondary	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
Secondary	Assess the percentage of children with psychomotor impairment at the age of 3,5 years in both groups.		42 months
Secondary	Assess how many children have had a hearing evaluation in both groups (excluding the newborn hearing screening).		42 months