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IRCT20140907019076N2 IRCT 2021-06-19 Mashhad University of Medical Sciences Effect of Oral Erythropoietin in neonatal with hypoxic ischemic encephalopathy Effect of Oral Erythropoietin on tolerance of oral feeding, Prevention of Complications and reduction of mortality in neonatal with hypoxic ischemic encephalopathy 2020-06-21 anticipated 100 Complete https://irct.ir/trial/51798 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study design is done in parallel in which the two groups are compared over time. The simple randomization method is using a table of random numbers using the site www.randomization.com. Concealment is done through sealed envelopes. The method of the envelope is that the envelopes will be prepared and printed by a member of the research team and random numbers with the help of Randomaize.com and placed inside the envelope. The lid of the envelope will be closed and its contents will not be visible from the outside. Then, the purpose of the study is first explained to the person who meets the conditions, and the person, if he wishes, signs the informed consent form and takes an envelope, and then opens it and enters the intervention or control group based on the contents of the envelope, Blinding description: The subjects and evaluators will be unaware of the intervention and control groups. 1 Ischemic hypoxic encephalopathy. Intervention 1: Intervention group: Erythropoietin is administered orally within the first 48 hours of birth dose 400 units per kg daily for 5 days (days 7, 5, 3, 1, 2) in addition to standard treatment for newborns. Intervention 2: Control group: newborns receive standard asphyxia treatment, including fluid restriction and placebo. The normal saline placebo will be given in the same amount as the oral or gastric catheter. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentified. When: Data can be accessible 6 months after results are published To whom: data can be accessible through an email to the corresponding author Conditions: Data will be available for researchers in universities and other scientific institution. Where to obtain: After sending a request email to the corresponding author, data will be sent in 1 month. How to obtain: Carrying out analysis on data is permitted Comments:
public Saeedeh Eshkil
Neonatal intensive care unite, Imam reza hospital, Ibn Sina Ave, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3852 1121 eshkils@mums.ac.ir Mashhad University of Medical Sciences scientific Saeedeh Eshkil
Neonatal intensive care unite, Imam Reza Hospital, Ibn Sina Ave,Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3852 1121 eshkils@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Gestational age more than and equal to 37 weeks prenatal asphyxia Grade 2 and 3 encephalopathy Conscious consent of parents 1 day 30 days Both Birth weight <2200 g A genetic or congenital disease that affects nerve growth or requires multiple surgeries Head circumference <30 cm Polycythemia The infant should participate in another intervention period during hospitalization Asphyxia cases without HIE Metabolic diseases Confirmed infection P91.6 Hypoxic ischemic encephalopathy [HIE] Placebo Placebo Intervention group: Erythropoietin is administered orally within the first 48 hours of birth dose 400 units per kg daily for 5 days (days 7, 5, 3, 1, 2) in addition to standard treatment for newborns. Control group: newborns receive standard asphyxia treatment, including fluid restriction and placebo. The normal saline placebo will be given in the same amount as the oral or gastric catheter. Effect of Oral Erythropoietin on tolerance of oral feeding, Prevention of Complications and reduction of mortality in neonatal with hypoxic ischemic encephalopathy. Timepoint: In the erythropoietin intervention group, orally within the first 48 hours of birth at a dose of 400 units per kilogram daily for 5 days (days 7,5,3,1,2). Method of measurement: By mouth or stomach catheter. Mashhad University of Medical Sciences Approved 2020-08-18 Ethics committee of MashhadUniversity of Medical Sciences Central Building of Mashhad University of Medical Sciencs (Ghorshi), Daneshgah 16, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)