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IRCT20230219057459N1 IRCT 2023-06-24 Kerman University of Medical Sciences Investigating the effect of injectable Acetaminophen in the treatment of Patent Ductus Arteriosus (PDA). A comparative study of the effectiveness of injectable Acetaminophen in closing Patent Ductus Arteriosus (PDA) in Term and Preterm Neonates. 2020-03-20 anticipated 80 Complete https://irct.ir/trial/68783 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The rand function of Excel software was used for randomization. Based on the random number obtained in the software, the infants are divided into two groups (intervention and control) and this process will continue for each group up to 40 people, Blinding description: In this study, the researcher is informed about the division of the groups, also the parents of the babies have received explanations about the objectives and how to conduct the research, but parents and babies do not know about the division of the groups (intervention or control). Also, the statistician analyzing the data does not know which of the groups the data collected during the study belongs to, and the coded data in two groups (A and B) were given to the expert and their analysis was done. 3 Neonatal Patent Ductus Arteriosus. Intervention 1: The intervention group: included the use of injectable acetaminophen by Amin company with a dose of 20 mg based on weight, in the first hour and 10 mg based on weight, for every six hours, for three days after the initial dose. Intervention 2: Control group: included the use of normal saline injection with a volume equal to the drug in the first hour and every six hours for three days after the initial dose. 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 There is no further information
public Mohammad Mehdi Bagheri
Afzalipur Hospital, Imam Khomeini Highway, Kerman town
Kerman Iran (Islamic Republic of) 7616913355 0098343138000 mehdi_b_ped@yahoo.com Kerman University of Medical Sciences scientific Mohammad Mahdi Bagheri
Afzalipur Hospital, Imam Khomeini Highway, Kerman
Kerman Iran (Islamic Republic of) 7616913355 +98 34 3132 8000 medi_b_ped@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) All hospitalized neonates with Patent Ductus Arteriosus(PDA) All term neonates with a gestational age of 37 weeks and more The minimum age is 3 days and the maximum age is 28 days. 3 days 28 days Both Congenital Heart Disease Multiple Congenital Anomalies Life Threatening Disease Asphyxia Lack of parental consent Q25.0 Patent ductus arteriosus Treatment - Drugs Treatment - Drugs The intervention group: included the use of injectable acetaminophen by Amin company with a dose of 20 mg based on weight, in the first hour and 10 mg based on weight, for every six hours, for three days after the initial dose. Control group: included the use of normal saline injection with a volume equal to the drug in the first hour and every six hours for three days after the initial dose. Closure of patent ductus arteriosus in neonates. Timepoint: Opening of the ductus arteriosus: before the start of the study and on the third day and the sixth day after receiving injectable acetaminophen. Method of measurement: Eco cardiography. Kerman University of Medical Sciences Approved 2022-01-10 Ethics Committee of Afzalipur Medical Education Center - Kerman University of Medical Sciences Afzalipur Hospital, Imam Khomeini Highway, Kerman town Kerman Kerman Iran (Islamic Republic of)