title: Enteral paracetamol or Intravenous Indomethacin for Closure of Patent Ductus Arteriosus in Preterm Neonates: A Randomized Controlled Trial.
abstract: OBJECTIVE
  To compare the efficacy of enteral paracetamol and intravenous indomethacin for closure of patent ductus arteriosus (PDA) in preterm neonates.
  
  
  METHODS
  Randomized controlled trial.
  
  
  METHODS
  Level III neonatal intensive care unit.
  
  
  METHODS
  77 preterm neonates with birth weight ?1500 g and PDA size ?1.5 mm, with left to right ductal flow with left atrium to aortic root ratio >1.5:1; diagnosed by 2D-Echo within first 48 hours of life.
  
  
  METHODS
  Paracetamol drops through the infant feeding tube (15 mg/kg/dose 6 hourly for 7 days) or intravenous indomethacin (0.2 mg/kg/dose once daily for 3 days).
  
  
  METHODS
  Primary: PDA closure rate assessed by echocardiography. Secondary: need for surgical closure of PDA, renal impairment, gastrointestinal bleed, necrotising enterocolitis, hepatotoxicity, pulmonary hemorrhage, sepsis, hypothermia, retinopathy of prematurity, intraventricular hemorrhage, bronchopulmonary dysplasia and mortality.
  
  
  RESULTS
  PDA closure rate was 100% (36/36) in enteral paracetamol group as compared to 94.6% (35/37) in intravenous indomethacin group (P=0.13). The secondary outcomes were also similar between the two groups. There was no occurrence of hepatotoxicity.
  
  
  CONCLUSIONS
  Enteral paracetamol is safe but not superior to intravenous indomethacin in the treatment of PDA in preterm neonates.
authors.affiliation: Department of Neonatology, Surya Childrens Hospital, Mangal Ashirwad, Santacruz West, Mumbai, India. Correspondence to: Dr Nandkishor S Kabra, Department of Neonatology, Surya Childrens Hospital, Mangal Ashirwad, Junction of S V Road and Dattatraya Road, Santacruz West, Mumbai 400 054, India. nskabra@gmail.com.
authors.forename: Swarup Kumar
authors.initials: SK
authors.lastname: Dash
authors.forename: Nandkishor S
authors.initials: NS
authors.lastname: Kabra
authors.forename: Bhupendra S
authors.initials: BS
authors.lastname: Avasthi
authors.forename: Shobha R
authors.initials: SR
authors.lastname: Sharma
authors.forename: Phalguni
authors.initials: P
authors.lastname: Padhi
authors.forename: Javed
authors.initials: J
authors.lastname: Ahmed
mesh_terms: D000082:Acetaminophen / Q000008:administration & dosage* / Q000009:adverse effects; D061605:Administration, Intravenous; D000328:Adult; D004374:Ductus Arteriosus, Patent / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007213:Indomethacin / Q000008:administration & dosage* / Q000009:adverse effects; D007231:Infant, Newborn; D007234:Infant, Premature; D019102:Infant, Very Low Birth Weight; D008297:Male
chemical_list: D000082:Acetaminophen; D007213:Indomethacin