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

Sponsor
Central Hospital, Nancy, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT04712760
Collaborator
(none)
60
Enrollment
1
Location
1.2
Anticipated Duration (Months)
48.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    60 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Congenital Hypothyroidism in Children With Eutopic Gland or Thyroid Hemiagenesis: Predictive Factors for Transient vs Permanent Hypothyroidism.
    Actual Study Start Date :
    Feb 22, 2021
    Anticipated Primary Completion Date :
    Mar 1, 2021
    Anticipated Study Completion Date :
    Apr 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Identify one or more predictive factors for transient congenital hypothyroidism in children with eutopic gland or thyroid hemiagenesis. [42 months]

    Secondary Outcome Measures

    1. 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]

    2. Assess the percentage of children with psychomotor impairment at the age of 3,5 years in both groups. [42 months]

    3. Assess how many children have had a hearing evaluation in both groups (excluding the newborn hearing screening). [42 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 42 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHRU Nancy Nancy France 54000

    Sponsors and Collaborators

    • Central Hospital, Nancy, France

    Investigators

    • Principal Investigator: Emeline Renard, MD, CHRU Nancy

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RENARD Emeline, MD, Central Hospital, Nancy, France
    ClinicalTrials.gov Identifier:
    NCT04712760
    Other Study ID Numbers:
    • 2020PI260
    First Posted:
    Jan 15, 2021
    Last Update Posted:
    Feb 23, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by RENARD Emeline, MD, Central Hospital, Nancy, France
    eutopic thyroid gland
    transient hypothyroidism
    Additional relevant MeSH terms:
    Congenital Hypothyroidism
    Hypothyroidism

    Study Results

    No Results Posted as of Feb 23, 2021