title: Serum ibuprofen levels of extremely preterm infants treated prophylactically with oral ibuprofen to prevent patent ductus arteriosus.
abstract: OBJECTIVE
  The aim of this study was to explore the effects of early oral ibuprofen administration on the incidence of hemodynamically significant patent ductus arteriosus (hsPDA) and define the association between serum ibuprofen levels and ductal closure.
  
  
  METHODS
  Preterm infants with a gestational age of <28 weeks and/or birth weight of <1,000 g were randomized either to the intervention (ibuprofen prophylaxis) or control group. The intervention group received oral ibuprofen 10 mg/kg within 12-24 h after birth followed by 5 mg/kg at 24 and 48 h. Serum ibuprofen levels after the treatment were analyzed in the intervention group, and the incidence of hsPDA and complication rates were compared between two groups.
  
  
  RESULTS
  Nineteen infants who received one course (three doses) of prophylactic ibuprofen in the intervention group and 17 infants in the control group who underwent an echocardiographic examination on the fourth day of life were analyzed. hsPDA was observed in five (26 %) infants in the intervention group and ten (58 %) infants in the control group (p = 0.09). In the intervention group two infants experienced gastrointestinal bleeding two infants had spontaneous intestinal perforation, and two infants developed acute kidney failure. Mean serum ibuprofen level was 28.7 ± 16.9 mg/L in the intervention group, and there was no correlation between ibuprofen level obtained on the fourth day and ductal closure.
  
  
  CONCLUSIONS
  Oral ibuprofen prophylaxis reduces the rates of hsPDA even it is not statistically significant. The ductal closure rate did not correlate with serum ibuprofen levels. Due to high prevalence of adverse events observed, our data do not support the use of oral ibuprofen for prophylaxis of hsPDA.
authors.affiliation: Division of Neonatology, Zekai Tahir Burak Maternity Teaching Hospital, Ankara, Turkey. gzdekanmaz@yahoo.com
authors.forename: Gozde
authors.initials: G
authors.lastname: Kanmaz
authors.forename: Omer
authors.initials: O
authors.lastname: Erdeve
authors.forename: Fuat Emre
authors.initials: FE
authors.lastname: Canpolat
authors.forename: Serife Suna
authors.initials: SS
authors.lastname: Oğuz
authors.forename: Nurdan
authors.initials: N
authors.lastname: Uras
authors.forename: Nahide
authors.initials: N
authors.lastname: Altug
authors.forename: Ben
authors.initials: B
authors.lastname: Greijdanus
authors.forename: Uğur
authors.initials: U
authors.lastname: Dilmen
mesh_terms: D000284:Administration, Oral; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D004374:Ductus Arteriosus, Patent / Q000188:drug therapy* / Q000517:prevention & control*; D005260:Female; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood* / Q000627:therapeutic use*; D062071:Infant, Extremely Premature / Q000097:blood*; D007231:Infant, Newborn; D008297:Male
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D007052:Ibuprofen