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IRCT2014090519050N1 IRCT 2015-02-02 Vice Chancellor for research of Tehran University of Medical Sciences The efficacy of prophylactic treatment with oral acetaminophen for closure of patent ductus arteriosus in preterm infants Investigation of efficacy rate of prophylactic treatment with oral paracetamol for closure of patent ductus arteriosus in preterm infants admitted in neonatal intensive care unit 2012-03-20 anticipated 30 Complete https://irct.ir/trial/17140 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. N/A patent ductus arteriosus. Intervention 1: Intervention group: Administration of 15mg/kg oral acetaminophen every 6 hours for 48 hours during first 24 hours after birth. Intervention 2: Control group: No intervention.
public Dr.Mohamad Reza Zarkesh
Tehran Women Hospital, North Nejatollahi Street, Karim Khan Zand Avenue
Tehran Iran (Islamic Republic of) +98 21 8889 7764 zarkesh@sina.tums.ac.ir Tehran University of Medical Sciences scientific Dr. Mohammad reza zarkesh
Tehran Women Hospital, North Nejatollahi Street, Karim Khan Zand Avenue
Tehran Iran (Islamic Republic of) +98 21 8889 7764 zarkesh@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Premature neonates born at or before 32 weeks of gestation with birth weight less than or equal to 1500 grams admitted in neonatal intensive care unit of Vali-e-Asr Hospital in 2012; parental consent for participating in this study. Exclusion criteria: Newborns with congenital heart defects that patency of ductus arteriosus is vital for them such as pulmonary atresia; congenital major anomalies or chromosomal abnormalities; maternal consumption of none steroidal anti-inflammatory drugs during pregnancy; newborns with hydrops fetalis or persistent pulmonary hypertension of the newborn; apgar score less than 5 at fifth minute after birth; appearance of patent of dutus arteriosus symptoms and requirement for treatment with Ibuprofen at any time; having vomiting or hematemesis during first 3 days after birth; neonates with glucose-6-phosphate dehydrogenase deficiency based on blood exam at beginning of neonatal admission no limit 6 days Both Q25.0 Congenital malformations of great arteries Treatment - Drugs N/A Intervention group: Administration of 15mg/kg oral acetaminophen every 6 hours for 48 hours during first 24 hours after birth Control group: No intervention Left Atrial to Aortic Ratio. Timepoint: 4-5 day of life. Method of measurement: Echocardiography. Internal Ductal Diameter. Timepoint: 4-5 day of life. Method of measurement: Echocardiography. Vice Chancellor for research of Tehran University of Medical Sciences Approved 2013-08-04 The Ethical Committee of Tehran University of Medical Science The Ethical Committee of Tehran University of Medical Science, Vice Chancellor for research, 6th Floor, Tehran University of Medical Sciences, Corner of Ghodss Street, Keshavarz Blvd. Tehran Iran (Islamic Republic of)