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IRCT20140907019076N3 IRCT 2021-09-29 Mashhad University of Medical Sciences Oral acetaminophen versus paracetamol in the preterm with persistent patent ductus arteriosus Oral acetaminophen versus paracetamol in the preterm with persistent patent ductus arteriosus admitted to the neonatal intensive care unit of Imam Reza (AS) Hospital in Mashhad 2020-08-22 anticipated 100 Complete https://irct.ir/trial/52006 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study design is done in parallel in which the two groups are compared over time. Method used to generate a random allocation sequence using the name of the software or site used: Table of random numbers using the site www.randomization.com The type of randomization is simple and the method of concealment is in the form of sealed envelopes, Blinding description: The evaluator and analyst will be unaware of the case and control groups. Patients will be blinded to the type of intervention and the researcher who must enter the data into the relevant checklist will be blinded to the type of intervention. 3 Patent ductus arteriosus. Intervention 1: Intervention group: ‎15 mg / kg prakid acetaminophen drop (100 mg/ml) will prescribed every 6 hours for 3 days and 15 mg / kg intravenous ‎acetaminophen every 6 hours for 3 days.‎. Intervention 2: Control group: Caspian Iranian intravenous acetaminophen at a dose of 15 mg / kg every 6 hours for 3 days. Yes - There is a plan to make this available What will be shared: All data can be shared after patients are made unidentifiable. 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 institute. 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 Atiyeh Eshkil
Imam Reza Hospital, Ibn Sina Ave, Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9137913316 38521121 eshkils941@mums.ac.ir Mashhad University of Medical Sciences scientific Atiyeh Eshkil
Imam Reza Hospital, Ibn Sina Ave, Mashhad, Iaran
Mashhad Iran (Islamic Republic of) 9137913316 38521121 eshkils941@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Preterm newborns with persistent patent ductus arteriosus by echocardiography pediatric cardiologist Parents' consent Gestational age less than 37weeks Birth weight less than 2000 gr 1 day 30 days Both Congenital heart disease that requires Patent ductus arteriosus (PDA) Liver diseases Active necrotizing enterocolitis or intestinal perforation Gastrointestinal bleeding Q25.0 Patent ductus arteriosus neonates Treatment - Drugs Treatment - Drugs Intervention group: ‎15 mg / kg prakid acetaminophen drop (100 mg/ml) will prescribed every 6 hours for 3 days and 15 mg / kg intravenous ‎acetaminophen every 6 hours for 3 days.‎ Control group: Caspian Iranian intravenous acetaminophen at a dose of 15 mg / kg every 6 hours for 3 days Persistent patent ductus arteriosus. Timepoint: Echocardiography before treatment and after treatment for 24 hours. Method of measurement: IPX7 echocardiography device with CA1-7AD curve probe is used for echocardiography. Arterial duct closure time. Timepoint: After the end of treatment. Method of measurement: Echocardiography. Number of courses of treatment. Timepoint: After diagnosis, it is treated for three days and if necessary, a three-day period is repeated. Method of measurement: Echocardiography. Medication side effects. Timepoint: Throughout the treatment and after the end of treatment. Method of measurement: Clinical signs and lab tests. Comorbidities and mortality. Timepoint: During treatment. Method of measurement: Clinical signs and lab tests. Mashhad University of Medical Sciences Approved 2020-08-18 Ethics committee of Mashhdad University of Medical Sciences Central building of Mashhad University of Medical Sciences (Ghorsi), Daneshgah 16, Daneshgah street Mashhad Razavi Khorasan Iran (Islamic Republic of)