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IRCT20130812014333N118 IRCT 2019-04-11 Kermanshah University of Medical Sciences Comparison of the effect of oral and rectal acetaminophen on the closure of ductus arteriosus in preterm neonates under 35 weeks and 6 days gestational old. Comparison of the therapeutic and Safety effect of oral and rectal acetaminophen for treatment and safety on the closure of ductus arteriosus in preterm neonates under 35 weeks and 6 days gestational old. 2019-03-16 anticipated 40 Complete https://irct.ir/trial/38155 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomly Individually by random number table via code receipt, Blinding description: In this study, Clinical care will be kept blind to study groups, the dosage of the drug and manufacturer of the drug. In this way,the clinicians are unaware of participants coding and the dose of the drug that groups will receive. 2-3 preterm neonates. Intervention 1: In the first intervention group, the treatment will begin with the administration of oral acetaminophen with a dose of 25 mg/kg body weight, then, will be administrated 15 mg per kg body weight every 8 hours for 3 days for babies over 1000 grams. Intervention 2: In the second intervention group, the treatment will begin with the administration of rectal acetaminophen with a dose of 25 mg/kg body weight, then, will be administrated 15 mg per kg body weight every 8 hours for 3 days for babies over 1000 grams. Yes - There is a plan to make this available What will be shared: The main outcomes of the study will be shared. When: 3 months To whom: If requested, results will be made available to other academic researchers Conditions: Collected data is confidential and will not be shared with anyone else Where to obtain: To receive the documentation, email send for update manager How to obtain: In a 15-day period, the documents will be sent e-mail Comments:
public Hashem Gholami
Crossroads of Shirkhorshid
Kermanshah Iran (Islamic Republic of) 6713733135 +98 83 3721 8204 gholami3280@gmail.com Kermanshah University of Medical Sciences scientific Dr. Mazyar Vakili Amini
Crossroads of Shirkhorshid
Kermanshah Iran (Islamic Republic of) 6713733135 +98 83 3721 8204 mzvakilia@kums.ac.ir Kermanshah University of Medical Sciences Iran (Islamic Republic of) Preterm neonates under 35 weeks and 6 days gestational old. Age after birth be over 72 hours and less than 14 days Neonates with hemodynamic disorders caused by PDA 3 days 14 days Both Respiratory rate more than 80 per minute Signs of renal failure and oliguria Creatinine clearance less than 10% P07.3 Other preterm neonates Treatment - Drugs Treatment - Drugs In the first intervention group, the treatment will begin with the administration of oral acetaminophen with a dose of 25 mg/kg body weight, then, will be administrated 15 mg per kg body weight every 8 hours for 3 days for babies over 1000 grams. In the second intervention group, the treatment will begin with the administration of rectal acetaminophen with a dose of 25 mg/kg body weight, then, will be administrated 15 mg per kg body weight every 8 hours for 3 days for babies over 1000 grams. The closure of ductus arteriosus. Timepoint: The beginning and end of the study. Method of measurement: With echocardiography device. Kermanshah University of Medical Sciences Approved 2019-03-06 Ethics committee of Kermanshah University of Medical Sciences Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Kermanshah Kermanshah Iran (Islamic Republic of)