Child, Only, Glucocorticoids, Immune Thrombocytopenia
Conditions
Brief summary
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)
Interventions
DRUGPrednisone
Prednisone 4mg/kg.d, d1-4
DRUGDexamethasone
Dexamethasone 0.6mg/kg.d, d1-4
Sponsors
The First Affiliated Hospital of Xiamen University
Zhangzhou Affiliated Hospital of Fujian Medical University
Quanzhou First Hospital
Nanping First Hospital Affiliated to Fujian Medical University
The Second Hospital of Anhui Medical University
The Affiliated Hospital Of Guizhou Medical University
Longyan City First Hospital
The Affiliated Hospital of Putian University
Fujian Medical University Union Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
29 Days to 14 Years
Healthy volunteers
No
Inclusion criteria
Subjects enrolled in this study must meet all of the following criteria: 1. Meet the ITP diagnostic criteria, within 3 months of the first diagnosis 2. Age \> 28 days and ≤ 14 years old 3. Untreated PLT\<20×109/L, or PLT\<30×109/L after 1 week of intravenous gamma globulin (IVIG) treatment 4. Have signed the informed consent
Exclusion criteria
Anyone who has any of the following conditions will not enter the clinical study: 1. 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.) 2. Received glucocorticoid therapy within 6 months 3. Menstrual female children 4. Patients with underlying diseases such as tumor diseases, autoimmune diseases or genetic diseases 5. Patients who have received radiotherapy and chemotherapy 6. There are contraindications to the use of glucocorticoids (hypertension, glaucoma, peptic ulcer, etc.) 7. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| initial treatment response | 30 days after treatment | Platelet count after glucocorticoid therapy 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | 1 month | Incidence of Treatment-Emergent Adverse Events occurring within 1 month of glucocorticoid therapy |
Countries
China
Contacts
Primary ContactYongzhi Zheng, PhD
Outcome results
None listed