title: Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial.
abstract: OBJECTIVE
  To compare the efficacy and safety of oral paracetamol and oral ibuprofen for the pharmacological closure of patent ductus arteriosus (PDA) in preterm infants.
  
  
  METHODS
  This prospective, randomized, controlled study enrolled 90 preterm infants with gestational age ≤ 30 weeks, birthweight ≤ 1250 g, and postnatal age 48 to 96 hours who had echocardiographically confirmed significant PDA. Each enrolled patient received either oral paracetamol (15 mg/kg every 6 hours for 3 days) or oral ibuprofen (initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 hours).
  
  
  RESULTS
  Spontaneous closure rate for the entire study group was 54%. After the first course of treatment, the PDA closed in 31 (77.5%) of the patients assigned to the oral ibuprofen group vs 29 (72.5%) of those enrolled in the oral paracetamol group (P = .6). The reopening rate was higher in the paracetamol group than in the ibuprofen group, but the reopening rates were not statistically different (24.1% [7 of 29] vs 16.1% [5 of 31]; P = .43). The cumulative closure rates after the second course of drugs were high in both groups. Only 2 patient (2.5%) in the paracetamol group and 3 patients (5%) in the ibuprofen group required surgical ligation.
  
  
  CONCLUSIONS
  This randomized, controlled clinical study compared oral paracetamol with ibuprofen in preterm infants and demonstrated that paracetamol may be a medical alternative in the management of PDA.
authors.affiliation: Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. Electronic address: dryekta@gmail.com.
authors.forename: Mehmet Yekta
authors.initials: MY
authors.lastname: Oncel
authors.affiliation: Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.
authors.forename: Sadik
authors.initials: S
authors.lastname: Yurttutan
authors.affiliation: Division of Neonatology, Department of Pediatrics, Ankara University School of Medicine, Ankara, Turkey.
authors.forename: Omer
authors.initials: O
authors.lastname: Erdeve
authors.affiliation: Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.
authors.forename: Nurdan
authors.initials: N
authors.lastname: Uras
authors.affiliation: Division of Pediatric Cardiology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.
authors.forename: Nahide
authors.initials: N
authors.lastname: Altug
authors.affiliation: Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.
authors.forename: Serife Suna
authors.initials: SS
authors.lastname: Oguz
authors.affiliation: Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey.
authors.forename: Fuat Emre
authors.initials: FE
authors.lastname: Canpolat
authors.affiliation: Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey; Department of Pediatrics, Yildirim Beyazit University School of Medicine, Ankara, Turkey.
authors.forename: Ugur
authors.initials: U
authors.lastname: Dilmen
mesh_terms: D000082:Acetaminophen / Q000627:therapeutic use*; D000284:Administration, Oral; D016861:Cyclooxygenase Inhibitors / Q000627:therapeutic use*; D004374:Ductus Arteriosus, Patent / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000601:surgery; D006801:Humans; D007052:Ibuprofen / Q000627:therapeutic use*; D007231:Infant, Newborn; D007234:Infant, Premature; D008026:Ligation / Q000706:statistics & numerical data; D011446:Prospective Studies; D014463:Ultrasonography
chemical_list: D016861:Cyclooxygenase Inhibitors; D000082:Acetaminophen; D007052:Ibuprofen