Efficacy and safety of rectal ibuprofen for patent ductus arteriosus closure in very low birth weight preterm infants

J Matern Fetal Neonatal Med. 2017 Sep;30(17):2119-2125. doi: 10.1080/14767058.2016.1238897. Epub 2017 Jan 25.

Abstract

Background: To compare rectal ibuprofen with oral ibuprofen for the closure of hemodynamically significant patent ductus arteriosus (hsPDA) in very low birth weight (VLBW) preterm infants.

Study design and subjects: In a prospective, randomized study, 72 VLBW infants who had hsPDA received either rectal or oral ibuprofen. The plasma concentration of ibuprofen and renal functions were determined in both groups by the high-performance liquid chromatography (HPLC) method and cystatin-C (cys-C), respectively.

Results: The hsPDA closure rate of the group that received rectal ibuprofen was similar to oral ibuprofen (86.1% versus 83.3%) after the first course of the treatment (p = 0.745). A statistically significant difference was identified between the mean plasma cys-C levels before and after treatment in both the rectal and oral ibuprofen groups (p = 0.004 and p< 0.001, respectively). The mean plasma ibuprofen concentration was similar in both groups after the first dose (rectal 44.06 ± 12.4; oral, 48.28 ± 22.8) and the third dose (rectal, 45.34 ± 24.3; oral, 48.94 ± 24.8) (p > 0.05 for all values).

Conclusions: Rectal ibuprofen is as effective as oral ibuprofen for hsPDA closure in VLBW infants. The rise in the cys-C level with rectal and oral treatment shows that patients with borderline renal function should be evaluated and followed closely.

Keywords: Ibuprofen; oral; patent ductus arteriosus; preterm; rectal.

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Administration, Rectal
  • Biomarkers / blood
  • Case-Control Studies
  • Cyclooxygenase Inhibitors / administration & dosage*
  • Cystatin C / blood
  • Ductus Arteriosus, Patent / drug therapy*
  • Echocardiography, Doppler
  • Female
  • Humans
  • Ibuprofen / administration & dosage*
  • Ibuprofen / blood
  • Infant, Newborn
  • Infant, Premature
  • Infant, Very Low Birth Weight
  • Male
  • Prospective Studies
  • Random Allocation
  • Statistics, Nonparametric
  • Treatment Outcome

Substances

  • Biomarkers
  • Cyclooxygenase Inhibitors
  • Cystatin C
  • Ibuprofen