Actively Recruiting

Age: 29Days - 14Years
All Genders
ID06570967

A Retrospective and Prospective Observational Study of Hyperthyroidism in Children

Led by Shengjing Hospital · Updated on 2024-08-27

1000

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to study children with hyperthyroidism by collecting information on their diagnosis, treatment, and long-term follow-up. The study focuses on understanding the clinical features, treatment effects, side effects, remission, and relapse of hyperthyroidism in children. It also investigates factors that predict the response to antithyroid drug treatment and explores risks linked to adverse reactions from these drugs. The study observes children treated with methimazole (MMI), a drug given initially at 0.2-0.8 mg per kilogram per day. The dose is gradually reduced and adjusted based on thyroid hormone test results to maintain normal thyroid function. This observational study includes both retrospective and prospective data collection without any intervention. Participants will be monitored over time to assess remission, defined as normal thyroid function without methimazole for at least 12 months, and adverse effects such as neutropenia, liver dysfunction, rash, and muscle or joint pain. Relapse after stopping methimazole will also be tracked. The study involves clinical evaluations, biochemical tests, and long-term follow-up lasting up to 10 years to understand treatment outcomes and safety.

CONDITIONS

Brief Title

A Clinical Study of Hyperthyroidism in Children

Who Can Participate

Age: 29Days - 14Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 14 years old or younger
  • Initial diagnosis of hyperthyroidism
Not Eligible

You will not qualify if you...

  • Hyperthyroidism previously treated with medication at other hospitals
  • History of autoimmune hepatitis, viral hepatitis, hematological diseases, bone marrow or liver transplantation
  • Patients with incomplete clinical data

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to 10 years

Participants receive methimazole medication with dosing adjusted based on thyroid hormone levels during follow-up visits.

Regular follow-up visits for dose adjustment and monitoring

Follow-up

Duration - Up to 10 years

Participants are monitored for remission, relapse, and adverse effects after methimazole treatment.

Periodic visits for clinical and biochemical assessments

Trial Site Locations

Total: 1 location

1

Shengjing Hospital of China Medical University

Shenyang, Liaoning, China, 110004

Actively Recruiting

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Research Team

S

Shi Tang, Doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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