title: Randomized Trial to Compare Renal Function and Ductal Response between Indomethacin and Ibuprofen Treatment in Extremely Low Birth Weight Infants.
abstract: A head to head comparison study on renal function and ductal response between indomethacin and ibuprofen has rarely been conducted in extremely low birth weight (ELBW) infants.
  
  
  
  The aim was to compare renal function and ductal response between indomethacin and ibuprofen in ELBW infants.
  
  
  
  We performed a double-blind randomized control trial to compare renal function and ductal response between indomethacin (0.2, 0.1, and 0.1 mg/kg i.v. every 24 h for 3 doses) and ibuprofen lysine (10, 5, and 5 mg/kg i.v. every 24 h for 3 doses) in ELBW infants with significant hemodynamic patent ductus arteriosus (cardiovascular dysfunction score >3 and LA/AO ratio ≥1.3).
  
  
  
  A total of 144 infants were enrolled: 73 received indomethacin and 71 received ibuprofen lysine. Significant decreases in urine output were seen in 30 infants (41%) in the indomethacin group and 15 (21%) in the ibuprofen group (p = 0.02). The indomethacin group was associated with a significantly higher chance of persistent ductal response than the ibuprofen group (66 vs. 49%, p = 0.046), but with a lower glomerular filtration rate on day 1, higher serum creatinine on days 1, 2, and 7, and lower urinary prostaglandin on days 2-7. Both groups were comparable in mortality and in bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, and retinopathy of prematurity morbidity.
  
  
  
  With the current dosage, ibuprofen had fewer renal side effects but was associated with a lower rate of persistent ductal closure in ELBW infants. The precise role of prostaglandin on renal tubular function in ELBW infants remains to be further investigated.
authors.affiliation: Department of Pediatrics, National Cheng-Kung University, Tainan, Taiwan, ROC.
authors.forename: Yuh Jyh
authors.initials: YJ
authors.lastname: Lin
authors.forename: Chung Ming
authors.initials: CM
authors.lastname: Chen
authors.forename: Virender K
authors.initials: VK
authors.lastname: Rehan
authors.forename: Adrian
authors.initials: A
authors.lastname: Florens
authors.forename: Shou Yien
authors.initials: SY
authors.lastname: Wu
authors.forename: Min Luen
authors.initials: ML
authors.lastname: Tsai
authors.forename: Yung T
authors.initials: YT
authors.lastname: Kuo
authors.forename: Fu Kuei
authors.initials: FK
authors.lastname: Huang
authors.forename: Tsu F
authors.initials: TF
authors.lastname: Yeh
mesh_terms: D003404:Creatinine / Q000097:blood; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage*; D004311:Double-Blind Method; D004373:Ductus Arteriosus / Q000187:drug effects; D004374:Ductus Arteriosus, Patent / Q000188:drug therapy* / Q000401:mortality; D004452:Echocardiography; D005260:Female; D005919:Glomerular Filtration Rate / Q000187:drug effects; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage / Q000627:therapeutic use*; D007213:Indomethacin / Q000008:administration & dosage / Q000627:therapeutic use*; D052577:Infant, Extremely Low Birth Weight; D007231:Infant, Newborn; D007668:Kidney / Q000187:drug effects* / Q000502:physiology; D008297:Male; D013624:Taiwan; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
chemical_list: D016861:Cyclooxygenase Inhibitors; D003404:Creatinine; D007052:Ibuprofen; D007213:Indomethacin