Efficacy of a single dose of Intravenous immune globulin (IVIG) (0.8 gr/Kg) vs tab Prednisolone (2mg/Kg) in pediatric newly diagnosed Immune thrombocytopenia (ITP)

Evaluation of the efficacy and safety of intravenous immunoglobulin and corticosteroid

The current study is an open label phase 3 clinical trial with parallel groups in which 100 newly diagnosed immune thrombocytopenia with a platelet count <10,000/dl will be studied. Participants after including the study, will be divided in two groups using a simple random method. One group of patients will receive intravenous immunoglobulin and the other will receive corticosteroids. The platelets number will be measured in order to find the effectiveness of each group in three intervals, including 48 hours, 7 days and one month after injection.

The current trial will be performed at Mofid Hospital on ITP patients. The participants included in the study will then randomly divided into two groups. Participants in the first group will receive IVIG at a dose of 0.8 mg/kg and in the second group will receive prednisolone 2 mg per kilogram of weight for seven days. During hospitalization, signs of bleeding symptoms will be gathered from patients. All process will be under the supervision of a pediatric hematologist

The participants includes patients referred to Mofid Hospital with an age range between one month and 17 years, a diagnosis of Immune thrombocytopenia (ITP) and a platelet count of less than 10,000/dL. Also, if there is severe bleeding, history of splenectomy, contraindications to receiving IVIG, history of receiving IVIG or recent corticosteroids, sepsis, high fever, splenomegaly, or DIC, they will be excluded from the study

Participants in the first intervention group will receive IVIG at a dose of 0.8 mg/kg and in the second intervention group will receive prednisolone 2 mg per kilogram of weight for seven days

Platelet count Bleeding symptom

Patients included in the study will be entered in two blocks, one group will receive intravenous immunoglobulin and the other will receive corticosteroids. In block dividing, we will ensure that exactly the same number of participants enter both of our intervention groups in consecutive but equal time intervals. However, in this study, due to the use of two blocks, there will be no possibility of blinding the information of some participants. Randomization in this study is done by a researcher in a simple random method. In this way, every new patient included in the study will enter one of the intervention groups randomly (using a lion coin or a line) and the next participant will enter the opposite group. The advantage of this method is the uniform distribution of participants in both groups both in terms of time and causes that there are not more participants in a certain group in a certain period of time. Also, if there is a lack of sample size in the sampling interval, it guarantees the equal number of people in the two groups.

The data of this article will be published in two ways. First of all, after the publication of the thesis of this article, it will be in the Research Vice-Chancellor of Shahid Beheshti University of Medical Sciences. Then an article from this data will be published in one of the domestic and foreign journals that will be available for public.

There will be no time limit on data access.

The data will be available for public access.

Data reanalysis will not be allowed under any circumstances.

To receive data and documents, send a message to the responsible author. Requests will only be answered via email. Applicants can send their application to the email address surgery1353@gmail.com.

After sending the request to the responsible author's e-mail, he will review it in general. Then, if there is no conflict of interest, all authors and researchers of the project will be informed. If the team agrees, the data will be provided to the applicant.