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

NCT04712760 | Unknown

• 1 other identifier: 2020PI260
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Hypothyroidism

Keywords

eutopic thyroid gland; transient hypothyroidism

Outcome Measures

Primary Outcomes (1)

• Identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis.

  42 months

Secondary Outcomes (3)

• 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

Study Arms (2)

Transient congenital hypothyroidism

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

Permanent congenital hypothyroidism

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

Eligibility Criteria

• Age: Up to 42 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with congenital hypothyroidism either detected by newborn screening or by a blood test done because of clinical suspicion of hypothyroidism, in Lorraine, between 1996 and 2017. All the patients with confirmed hypothyroidism underwent thyroid imaging. The children with eutopic gland and hemiagenesis are included in this study.

You may qualify if:

• 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.

You may not qualify if:

• Polymalformative syndrome
• Thyroid dysgenesis except for thyroid hemiagenesis

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

CHRU Nancy

Nancy, 54000, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 36798001 DERIVED

MeSH Terms

Conditions

Congenital Hypothyroidism

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases; Hypothyroidism; Thyroid Diseases

Study Officials

• Emeline Renard, MD

  CHRU Nancy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emeline Renard, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 15, 2021
• Study Start: February 22, 2021
• Primary Completion: March 1, 2021
• Study Completion: April 1, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Locations

FR (1)