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IRCT20190505043478N1 IRCT 2019-05-10 Iran University of Medical Sciences Comparison of the efficacy of oral Acetaminophen and intravenous Acetaminophen for closure of patent ductus arteriosus in preterm neonates Comparison of the efficacy of oral Acetaminophen and intravenous Acetaminophen for closure of patent ductus arteriosus in preterm neonates admitted in neonatal intensive care unit of Akbar Abadi Hospital 2019-04-21 anticipated 100 Complete https://irct.ir/trial/39364 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 100 premature neonate assigned with simple randomization, according to table of random number and individual randomization unit. 50 neonates in the first intervention group and 50 neonates in the second intervention group were selected. In this study, do not allocation concealment. 3 Patent ductus arteriosus (PDA). Intervention 1: Intervention group 1: Includes premature neonates with PDA diagnosis by pediatric cardiologist. In this group, samples (n=50) received oral Acetaminophen at a dose of 15mg / kg every 6 hours for 3 days. Intervention 2: Intervention group2: Includes premature neonates with PDA diagnosis by pediatric cardiologist. In this group, samples (n=50) received IV Acetaminophen at a dose of 15mg / kg every 6 hours for 3 days. 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 Shadi Adib
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 shadiadib95@gmail.com Iran University of Medical Sciences scientific Shadi Adib
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 shadiadib95@gmail.com Iran University of Medical Sciences Iran (Islamic Republic of) Written parental consent is obtained Gestational age 26 to 37 weeks Diagnosis of ductus arteriosus based on echocardiographic evidence at 24 to 72 hours after birth 1 day 20 days Both No Parental consent Any congenital heart disease with the need to PDA to keep blood flow constant ( Based on patient records). Life threatening infections .( Based on patient records) Liver Disease Q25.0 Patent ductus arteriosus Treatment - Drugs Treatment - Drugs Intervention group 1: Includes premature neonates with PDA diagnosis by pediatric cardiologist. In this group, samples (n=50) received oral Acetaminophen at a dose of 15mg / kg every 6 hours for 3 days. Intervention group2: Includes premature neonates with PDA diagnosis by pediatric cardiologist. In this group, samples (n=50) received IV Acetaminophen at a dose of 15mg / kg every 6 hours for 3 days. PDA size. Timepoint: The neonates receives echocardiography before and after treatment. Method of measurement: Patient PDA evaluated before and after treatment, based on severity of the disease, and findings of the echocardiography by pediatiric's cardiologist . Iran University of Medical Sciences Approved 2019-04-16 Ethics committee of Iran University of Medical Sciences No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital Tehran Tehran Iran (Islamic Republic of)