Short-course High-dose Prednisone and Dexamethasone in Children With ITP

Study Overview
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Brief Summary
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Comparison of the efficacy and safety of short-course high-dose prednisone and dexamethasone in the treatment of children with newly diagnosed immune thrombocytopenia (ITP)

Official Title
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Short-course High-dose Prednisone and Dexamethasone in Children With Immune A Multicenter, Randomized Controlled Study of Thrombocytopenia

Conditions
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Immune Thrombocytopenia, Glucocorticoids, Child, Only

Intervention / Treatment
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* Drug: Prednisone
* Drug: Dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:Subjects enrolled in this study must meet all of the following criteria: Meet the ITP diagnostic criteria, within 3 months of the first diagnosis Age > 28 days and ≤ 14 years old Untreated PLT<20×109/L, or PLT<30×109/L after 1 week of intravenous gamma globulin (IVIG) treatment Have signed the informed consent Exclusion Criteria:Anyone who has any of the following conditions will not enter the clinical study: Intracranial hemorrhage or severe gastrointestinal or urinary tract hemorrhage requiring emergency treatment, such as simultaneous use of platelet transfusion and thrombopoietic drugs (recombinant human thrombopoietin, eltrombopag, etc.) Received glucocorticoid therapy within 6 months Menstrual female children Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases Patients who have received radiotherapy and chemotherapy There are contraindications to the use of glucocorticoids (hypertension, glaucoma, peptic ulcer, etc.) There are any significant abnormal coexisting diseases or mental illnesses that affect the patient's life safety and compliance, and affect informed consent, research participation, follow-up or interpretation of results

Ages Eligible for Study
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Minimum Age: 29 Days
Maximum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prednisone group<br>prednisone 4mg/kg.d | Drug: Prednisone<br>* Prednisone 4mg/kg.d, d1-4<br>|
| Active Comparator: Dexamethasone<br>Dexamethasone 0.6mg/kg.d | Drug: Dexamethasone<br>* Dexamethasone 0.6mg/kg.d, d1-4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| initial treatment response | Platelet count after glucocorticoid therapy 1 month | 30 days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of Treatment-Emergent Adverse Events occurring within 1 month of glucocorticoid therapy | 1 month |