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

February 21, 2021 updated by: RENARD Emeline, Central Hospital, Nancy, France
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Nancy, France, 54000
        • Recruiting
        • CHRU Nancy
        • Contact:
        • Sub-Investigator:
          • Sylvie Hélène Bontemps

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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.
Time Frame: 6 months, 1 year, 2 years, 3 years
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.
Time Frame: 42 months
42 months
Assess how many children have had a hearing evaluation in both groups (excluding the newborn hearing screening).
Time Frame: 42 months
42 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Central Hospital, Nancy, France

Investigators

  • Principal Investigator: Emeline Renard, MD, CHRU Nancy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 22, 2021

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

April 1, 2021

Study Registration Dates

First Submitted

January 11, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

February 23, 2021

Last Update Submitted That Met QC Criteria

February 21, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020PI260

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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