A Clinical Study of Hyperthyroidism in Children

NCT06570967 | Recruiting

• 1 other identifier: 1223
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study intends to conduct a retrospective and prospective study on children with hyperthyroidism, and it is a non-intervention study to collect information on diagnosis and treatment and long-term follow-up of children with hyperthyroidism. To investigate the clinical characteristics, treatment effect, side effects and remission of hyperthyroidism in children, to analyze the predictive factors for the effect of antithyroid drug treatment, remission and recurrence after drug withdrawal, and to explore the risk factors related to the occurrence of antithyroid drug-related adverse reactions.

Conditions

Hyperthyroidism

Outcome Measures

Primary Outcomes (2)

• Remission of hyperthyroidism in children treated with methimazole. Remission is defined as having clinical and biochemical euthyroidism(FT3, FT4 and TSH are normal) without methimazole treatment for at least 12 months.

  To analyze the therapeutic effect of methimazole and the predictors of remission of hyperthyroidism after methimazole treatment.

  10 years

• Adverse effects of methimazole in the treatment of hyperthyroidism in children. Adverse effects are defined as having neutropenia (absolute neutrophil count< 1500/µL), liver dysfunction (AST or ALT> 60 IU/L), rash, arthralgia, myalgia, et al.

  Analyze the adverse reaction of methimazole treatment in hyperthyroidism children. Explore the risk factors related to the occurrence of methimazole related adverse reactions.

  1 year

Secondary Outcomes (1)

• Relapse of hyperthyroidism in children treated with methimazole. Relapse was defined as having clinical and biochemical hyperthyroidism (FT3 and FT4 increased and TSH decreased) after discontinuation of methimazole.

  10 years

Interventions

Methimazole(MMI) DRUG

The initial dose of methimazole was 0.2-0.8 mg/(kg▪d). This dose was subsequently reduced by 25% to 50% and adjusted to maintain euthyroidism, based on the results of serum thyroid hormone testing during follow-up.

Eligibility Criteria

• Age: 29 Days - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population included male and female with hyperthyroidism aged no more than 14 years. Participants must have not been treated with medication in other hospitals, have no history of autoimmune hepatitis, viral hepatitis, hematological diseases, bone marrow or liver transplantation, and have complete clinical data.

You may qualify if:

• Age ≤14 years old
• Initial diagnosis of hyperthyroidism

You may not qualify if:

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

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

RECRUITING

MeSH Terms

Conditions

Hyperthyroidism

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases

Central Study Contacts

Shi Tang, Doctor

CONTACT

+8618940259064; ts047827@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: August 13, 2024
• First Posted: August 26, 2024
• Study Start: July 18, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)