A Clinical Study of Hyperthyroidism in Children
ConditionHyperthyroidism
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age29-14
SponsorShengjing Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≤14 years old
Initial diagnosis of hyperthyroidism
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Methimazole(MMI)
DrugThe 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
10 years2
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.
Time frame
1 yearSecondary 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.
The risk factors of relapse in children with hyperthyroidism treated with MMI were analyzed
Time frame
10 yearsSponsors and contacts
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Source ClinicalTrials.gov