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IRCT20170801035441N1 IRCT 2018-07-09 Esfahan University of Medical Sciences "Evaluation of the effect of oral acetaminophen on the treatment of neonatal PDAs" Comparison of the effect of oral Acetaminophen with oral Ibuprofen in closure of Patent ductus arteriosus (PDA) in preterm neonate with gestational age less than 32 weeks 2018-06-22 anticipated 40 Complete https://irct.ir/trial/31705 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, neonates in need of treatment will be divided into two groups using random numbers and each group will receive standard treatment, Blinding description: In this study, nursing staff have no information about type of treatment. Only protocol 1 and 2 were recorded in follow-up treatment, so the next assessment was blinded by cardiology services, and it was only during the analysis of these protocols that the type of treatment was identified. 2 Patent ductus arteriosus. Intervention 1: Intervention group: For 48 hours, Drop of Acetaminophen made by the kimia gar Pharma Company at a dose of 15 mg / kg every 6 hours, given through the NG tube or through the dropper, by a nurse trained in neonates. Intervention 2: Control group: Oral Ibuprofen 10 mg / kg on day one and then two doses of 5mg / kg at 24 and 48 hours after administration of the dropper or through the NG tube and administered by a trained NICU nurse. Yes - There is a plan to make this available What will be shared: A portion of the data will be shared after the non-identifiable patients of study that contain the results of the treatment of Acetaminophen and also the demographic information of the patients. When: Three months after the publication of the results as an article. To whom: The data is available to researcher working in medical sciences. Conditions: researcher who are doing in pediatric cardiology is available. Where to obtain: To find out the data of this research, you can email Amir Binazadeh Resident of pediateric by e-mail. How to obtain: To access the research data after the request is sent, the researcher will be informed by email within 2 weeks for the delivery of the data to the applicant. Comments:
public Amir Banazade
No 42 ,Sajadie 2 Alley , Artesh Blvd
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3668 5321 amir_banazade@yahoo.com Esfahan University of Medical Sciences scientific Mehdi Ghaderian
no 34, Alley 16,Chaharbaghe Paein st
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3335 5881 m.ghaderian@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) All neonate with 32 weeks or less requiring PDA treatment for clinical conditions PDA is confirmed by echocardiography Age less than 14 days 1 day 14 days Both Congenital heart disease Clinical and laboratory symptoms of sepsis Chromosomal or congenital abnormalities The presence of Ibuprofen is contraindicated Q25.0 Patent ductus arteriosus Treatment - Drugs Treatment - Drugs Intervention group: For 48 hours, Drop of Acetaminophen made by the kimia gar Pharma Company at a dose of 15 mg / kg every 6 hours, given through the NG tube or through the dropper, by a nurse trained in neonates. Control group: Oral Ibuprofen 10 mg / kg on day one and then two doses of 5mg / kg at 24 and 48 hours after administration of the dropper or through the NG tube and administered by a trained NICU nurse. The closure rate of patent ductus arteriosus (PDA). Timepoint: Echocardiography at the beginning of the study and then 48-72 hours after treatment. Method of measurement: Confirmed by echocardiography. Esfahan University of Medical Sciences Approved 2018-03-07 Ethics committee of isfahan University of Medical Sciences Isfahan University of Medical Sciences and Health Services, hezar Jereyb St. isfahan Isfehan Iran (Islamic Republic of)