]>
IRCT20170910036112N2 IRCT 2018-03-04 Kashan University of Medical Sciences Efficacy of Paracetamol in treatment of patent dactus arteriosus in neonates _ Efficacy of Paracetamol versus Ibuprofen for the treatment of patent ductus arteriosus in neonates 2017-09-11 anticipated 60 Complete https://irct.ir/trial/27091 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual randomization will be used and the allocation schedule will be planned using a computerized randomization. Infants with patent dactus arteriosus will be randomly assigned to either intravenous acetaminophen or oral ibuprofen. For blinding, a trained nurse with no clinical involvement in the trial, will assign the infants to the groups according to the random allocation sequence, Blinding description: In this study, neonates with symptoms of patent ductus arteriosus (PDA) undergo echocardiagraphy by a cardiologist who has no information on neonates’ individual characteristics. Those neonates who meet the PDA diagnosis criteria and need treatment are assigned to different drug groups are unknown to the cardiologist. The diagnosed neonates are categorized to groups A and B according to the specific defined plans and receive treatment. The researcher is not aware of the type of treatment. Finally, echocardiography will be repeated for diagnosed neonates for the second time while the cardiologist is not still aware of the type of the treatment. 3 Patent ductus arteriosus in neonate. Intervention 1: Intervention group 2: Oral Ibuprofen 10mg/kg/dose for first day and 5mg/kg/dose for second and third day. Intervention 2: Intervention group 1: Intra venous Paracetamol 15mg/kg/dose every 6hours 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 more data
public Dr. Sima Safaei
Kashan University of Medical Scienses, Ghotbe Ravandi Blvd, Kashan, Iran
Kashan Iran (Islamic Republic of) 8715981151 +93 155540026 sima_safa@yahoo.com Kashan University of Medical Scienses scientific Dr. Ali Mohammad Shakiba
Kashan University of Medical Scienses, Ghotbe Ravandi Blnd, Kashan, Iran
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0026 shakibaa@sums.ac.ir Kashan University of Medical Scienses Iran (Islamic Republic of) All neonates with post natal age more than 3 days with hemodynamically significant PDA; Acceptance of inform consent by parents. 3 days 7 days Both All congenital heart diseases other than PDA Contraindication of using ibuprofen or acetaminophen Persistence fetal circulation (PFC) Q25.0 Patent Ductus Arteriosus Treatment - Drugs Treatment - Drugs Intervention group 2: Oral Ibuprofen 10mg/kg/dose for first day and 5mg/kg/dose for second and third day Intervention group 1: Intra venous Paracetamol 15mg/kg/dose every 6hours for 3 days Closure of PDA in neonate. Timepoint: 72 hours after birth and after 3 days of therapy initiation (therapy completion). Method of measurement: Echocardiography. _. Timepoint: _. Method of measurement: _. Kashan University of Medical Sciences Approved 2017-03-08 Ethics committee of Kashan University of Medical Sciences Kashan University of Medical Scienses, Ghotbe Ravandi Blvd, Kashan, Iran Kashan Isfehan Iran (Islamic Republic of)