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IRCT20190204042618N1 IRCT 2019-02-15 Shahre-kord University of Medical Sciences The effects of Ibupropen on term infants arterial duct The Effect of oral Ibuprofen in term Infants with Patent Dactus Arteriosus 2018-07-11 anticipated 40 Complete https://irct.ir/trial/37390 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization,The assignment of infants to these two groups is done in such a way that the infants parents choose a card from 40 colored cards that are designed in two different colors and according to the chosen color the infant goes to one of the two groups (Each card belongs to one of the study cases.), Blinding description: After conducting echocardiography and confirming the presence of Patent dactus arteriosus by the doctor, infant's parents go to the secretary and By choosing a card, they randomly go to one of the two groups of interventions.Then the secretary Based on the relevant group, gives the infant's parent ibuprofen susp and explains how and how much it is consumed or dose not give any drug .she records the required information in the list. Also in reoccurrence to examine the closure of the arterial duct, echo results recorded by the secretary in the previous checklist. So the doctor, who evaluates the ductus arteriosus closure does not know the allocation of newborns to study groups. 3 Patent Dactus Arteriosus. Intervention 1: Intervention group: reciving Ibuprofen, as an oral aqueous suspension (100 mg/5 ml;Alborz pharmaceutical) with a dose of 10 mg/kg at the beginning and four doses of 5 mg/kg with 24 hours intervals. Intervention 2: Control group: reciving no drug. 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 I will decide until the end of the study
public Dr. Nabi Allah Asadpour
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3224 8235 n.asadpour@skums.ac.ir Shahre-kord University of Medical Sciences scientific Dr. Nabi Allah Asadpour
Shahrekord University of Medical Sciences, Building No. 2, University headquarters, Ayatollah Kashani Blvd
Shahrekord Iran (Islamic Republic of) 8815713471 +98 38 3227 4004 N.asadpour@skums.ac.ir Shahre-kord University of Medical Sciences Iran (Islamic Republic of) Gestational age more than 37 weeks Age between 5 and 30 days old Patent dactus arteriosus size more than 1.5 mm detected by echocardiography 5 days 30 days Both Having ductal dependent congenital heart disease Creatinine more than 88.5 micromol/l Platelet count less than 50000 Q25.0 Patent ductus arteriosus Treatment - Drugs Treatment - Drugs Intervention group: reciving Ibuprofen, as an oral aqueous suspension (100 mg/5 ml;Alborz pharmaceutical) with a dose of 10 mg/kg at the beginning and four doses of 5 mg/kg with 24 hours intervals Control group: reciving no drug Patent Dactus Arteriosus closure. Timepoint: Day one, Day 7 after intervention. Method of measurement: Eco cardiography. Shahre-kord University of Medical Sciences Approved 2018-06-24 Ethics Committee of Shahrekord University of Medical Sciences Vice chancellor for research, Building No. 2, University headquarters, Ayatollah Kashani Blvd Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)