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IRCT20200218046538N1 IRCT 2020-03-10 Zahedan University of Medical Sciences Effect of acetaminophen in patent ductus arteriosus PDA Effect of prophylactic oral administration of acetaminophen on patent ductus arteriosus(PDA) closure in preterm neonate admitted in NICU section of Ali ibn Abitaleb Hospital in Zahedan in 2019-2020 2019-10-23 anticipated 106 Complete https://irct.ir/trial/45975 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible neonates are divided into two groups according to the random number table. Neonates with even numbers will be in the intervention group and neonates with odd numbers will be in the control group, Blinding description: The cardiologist that performs Echocardiography He Does not know that which neonate Received Acetaminophen. 2-3 Patent ductus arteriosus. Intervention 1: Intervention group: premature babies with gestational age less than 32 weeks and weight less than 1500 g inter to study Then, from the first day of birth, oral acetaminophen will be given to the infant at 15 mg / kg every 6 hours, and on the fifth day the echocardiography will be performed. Intervention 2: Control group: no intrvention is performed in this group and echocardiography will also be performed on the fifth day of birth without any intervention. Yes - There is a plan to make this available What will be shared: All patient information is available by patient code When: From the next 6 months To whom: All body Conditions: Use data to conduct research that is relevant to the health of the community and individuals Where to obtain: If you are approved by the university, you will be given a patient code if approved How to obtain: If you are approved by the university, you will be given a patient code if approved Comments:
public Somayeh Baghiei
Sadra street, Ziba shahr, Zahedan
Zahedan Iran (Islamic Republic of) 9817957671 +98 51 4261 4781 Som_baghiei1365@vatanmail.ir Zahedan University of Medical Sciences scientific Somayeh Baghiei
Sadra 22, Sadra street, Ziba shahr, Zahedan
Zahedan Iran (Islamic Republic of) 9817957671 +98 51 4261 4781 Som_baghiei1365@vatanmail.ir Zahedan University of Medical Sciences Iran (Islamic Republic of) All of preterm neonat Gestational آگه less than 32 week Weight less than 1500 gram 1 day 5 days Both Congenital heart disease Major congenital anomaly Use of NSAID in pregnancy with mother Persistant pulmonary hypertention APGAR scor less than 5 Vomitting or hematemesis G6PD deficency Sepsis Intra ventricular hemorrage Urin out put less than 1 cc/kg/hr Cr more than 1/8 mg/dl Plt less than 50000 NEC Q20.8 Other congenital malformations of cardiac chambers and connections Treatment - Drugs N/A Intervention group: premature babies with gestational age less than 32 weeks and weight less than 1500 g inter to study Then, from the first day of birth, oral acetaminophen will be given to the infant at 15 mg / kg every 6 hours, and on the fifth day the echocardiography will be performed. Control group: no intrvention is performed in this group and echocardiography will also be performed on the fifth day of birth without any intervention. Percentage of patent ductus arteriosus closure in preterm infants. Timepoint: Percentage of patent ductus arteriosus closure in preterm infants on fifth day of birth. Method of measurement: Echocardiography. Zahedan University of Medical Sciences Approved 2019-10-08 Ethics Committee of Zahedan University of Medical Sciences Sadra street, sadra 22 Zahedan Sistan-va-Balouchestan Iran (Islamic Republic of)