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IRCT20211010052715N1 IRCT 2021-11-25 Iran University of Medical Sciences Comparison of the efficacy of oral Acetaminophen and oral Ibuprofen for treatment of preterm with patent ductus arteriosus Comparison of the efficacy of oral Acetaminophen and oral Ibuprofen for treatment of preterm with patent ductus arteriosus 2021-04-21 anticipated 60 Complete https://irct.ir/trial/59624 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization method is used with blocks of sizes 4 , 6 and 8. The website https://www.sealedenvelope.com is used to create a randomization list. The blocks are randomly selected using this website and given to a researcher who is not involved in choosing the type of drug. Each random chain generated contains a unique code for concealment. The drug regimen is placed in envelopes according to random chains, and after sealing it on the envelopes, the specific number created by the site is written and the envelopes are randomly placed in a box. a box, Blinding description: This study is single-blinded and patients are unaware of the type of medication received. How to blind patients: Acetaminophen and Ibuprofen are both taken orally and given to infants 1-3 days old with a dropper. 3 Patent ductus arteriosus (PDA). Intervention 1: Intervention group: Includes premature neonates with PDA diagnosis by pediatric cardiologist. In this group, samples (n=30) received oral Acetaminophen at a dose of 15mg / kg every 8 hours for 3 days. Intervention 2: Intervention group: Includes premature neonates with PDA diagnosis by pediatric cardiologist. In this group, samples (n=30) received oral Ibuprofen at a dose of 10mg / kg every 8 hours 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 further information
public Zahra Hadadi
No 193, Aliasghar Children's Hospital, Zfar st, Moda
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6253 hadadi.za@iums.ac.ir Iran University of Medical Sciences scientific Semira Mehralizadeh
No. 193, Vahid dastgerdy Ave, Modares highway, Aliasghar Children Hospital
Tehran Iran (Islamic Republic of) 1919816766 +98 21 2304 6387 mehralizadehmd@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Parent's consent to participate in the study Gestational age 26 to 37 weeks Diagnosis of ductus arteriosus based on echocardiographic evidence at 24 to 72 hours after birth 1 day 3 days Both Premature newborn with fever and seizure Life-threatening infections, Clinical or radiographic evidence of necrotizing enterocolitis Evidence of bleeding Platelets less than 50,000 per ml Liver failure Congenital brain-neurological disorders, Metabolic and genetic syndromes Pulmonary hypoplasia syndrome Congenital heart anomalies or other fatal abnormalities Q25.0 Patent ductus arteriosus Treatment - Drugs Treatment - Drugs Intervention group: Includes premature neonates with PDA diagnosis by pediatric cardiologist. In this group, samples (n=30) received oral Acetaminophen at a dose of 15mg / kg every 8 hours for 3 days. Intervention group: Includes premature neonates with PDA diagnosis by pediatric cardiologist. In this group, samples (n=30) received oral Ibuprofen at a dose of 10mg / kg every 8 hours for 3 days. PDA size. Timepoint: Before and after the intervention. Method of measurement: Echocardiography by pediatiric's cardiologist . Iran University of Medical Sciences Approved 2021-04-12 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Hemat highway next to the Milad tower. Tehran Tehran Iran (Islamic Republic of)