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IRCT20120215009014N334 IRCT 2020-01-16 Hamedan University of Medical Sciences Effect of erythropoietin versus control group on the short-term prognosis in newborns with hypoxic- ischemic- encephalopathy Effect of erythropoietin versus control group on the short-term prognosis in newborns with hypoxic- ischemic- encephalopathy: a randomized clinical trial 2020-02-04 anticipated 64 Complete https://irct.ir/trial/45029 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random assignment of the patients to the intervention and control groups through the drawing of lots. To do this, we prepare two sheets and write "intervention" on one sheet and "control" on another. Then, by referring each patient, one of the sheets will be randomly taken and the patient will be assigned to the intervention or control group. 2 Hypoxic ischemic encephalopathy. Intervention 1: Intervention group: Routine treatment plus intravenous injection of erythropoietin 1000 U/kg/day on the first, second and third days and then every other day on the fifth, seventh, and ninth days to a maximum of 6 doses. Intervention 2: Control group: Just routine treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It depends on the situations and the results of the study as well as the approval of the financial supporting organization.
public Dr Tayebeh Ghalandari Navideh
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 911 432 1196 dr.ghalandari1@gmail.com Hamedan University of Medical Sciences scientific Dr. Behnaz Basiri
School of Medicine, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3838 0572 b.basiri@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Newborn, Hypoxic- ischemic- encephalopathy 1 day 28 days Both Congenital anomalies, Gestational age less than 36 weeks, Unperforated anus, Intracranial hemorrhage P91.6 Hypoxic ischemic encephalopathy [HIE] Treatment - Drugs N/A Intervention group: Routine treatment plus intravenous injection of erythropoietin 1000 U/kg/day on the first, second and third days and then every other day on the fifth, seventh, and ninth days to a maximum of 6 doses Control group: Just routine treatment Seizure attacks. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: With clinical examination. Time of onset of consciousness. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: With clinical examination. Occurrence of death. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: With clinical examination. Duration of hospitalization. Timepoint: From the beginning of the intervention to two weeks thereafter. Method of measurement: Based on the medical document. Time to start oral nutrition. Timepoint: From the beginning of the intervention until two weeks thereafter. Method of measurement: By taking a history. Drug complications such as induced topical hypothermia, bradycardia and subcutaneous necrosis. Timepoint: From the beginning of the intervention until two weeks later. Method of measurement: With clinical examination. Drug complications such as thrombocytopenia. Timepoint: From the beginning of the intervention up to two weeks later. Method of measurement: By laboratory tests. Hamedan University of Medical Sciences Approved 2019-12-07 Ethics Committee of Hamadan University of Medical Sciences Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave Hamadan Hamadan Iran (Islamic Republic of)