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

NCT ID: NCT04712760

Last Updated: 2021-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-02-22

Study Completion Date

2021-04-01

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.

Detailed Description

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Conditions

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Congenital Hypothyroidism

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Transient congenital hypothyroidism

\- children with congenital hypothyroidism who are no longer treated with Levothyroxine at an age of 3 years and 6 months

No interventions assigned to this group

Permanent congenital hypothyroidism

\- children with congenital hypothyroidism who are still treated with Levothyroxine at an age of 3 years and 6 months

No interventions assigned to this group

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
Maximum Eligible Age

42 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

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RENARD Emeline

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emeline Renard, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Locations

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CHRU Nancy

Nancy, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Emeline Renard, MD

Role: CONTACT

+33 3 83 15 45 00

Facility Contacts

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Emeline Renard, MD

Role: primary

+33 3 83 15 45 00

References

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Bontemps SH, Legagneur C, Gueant-Rodriguez RM, Remen T, Luc A, Renard E. Congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis: prognostic factors for transient vs. permanent hypothyroidism. J Pediatr Endocrinol Metab. 2023 Feb 20;36(4):353-363. doi: 10.1515/jpem-2022-0101. Print 2023 Apr 25.

Reference Type DERIVED
PMID: 36798001 (View on PubMed)

Other Identifiers

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2020PI260

Identifier Type: -

Identifier Source: org_study_id

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