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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04712760

Enrollment

Registered

2021-01-15

Start date

2021-02-22

Completion date

2021-04-01

Last updated

2021-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Hypothyroidism

Keywords

eutopic thyroid gland, transient hypothyroidism

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 42 Months

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

France

Contacts

Primary ContactEmeline Renard, MD

e.renard@chru-nancy.fr+33 3 83 15 45 00

Outcome results