BACKGROUND:Ibuprofen is used for treatment and prevention of patent ductus arteriosus in low-birthweight infants. Its effects on regional circulations differ from those of indometacin. Because prophylactic indometacin reduces the frequency of severe intraventricular haemorrhage and patent ductus arteriosus, we aimed to study the efficacy of early ibuprofen in reducing these outcomes in a double-blind, multicentre trial. METHODS: Within 6 h after birth, 415 low-birthweight infants (gestational age <31 weeks) were randomly allocated ibuprofen-lysine (10 mg/kg then two doses of 5 mg/kg after 24 h and 48 h) or placebo intravenously. The primary outcome was occurrence of severe intraventricular haemorrhage; secondary outcomes were occurrence of patent ductus arteriosus and possible adverse effects of ibuprofen. Analysis was by intention to treat. FINDINGS: 17 (8%) of 205 infants assigned ibuprofen and 18 (9%) of 210 assigned placebo developed severe intraventricular haemorrhage (relative risk 0.97 [95% CI 0.51-1.82]). In 172 (84%) infants of the ibuprofen group, the ductus was closed on day 3 compared with 126 (60%) of the placebo group (relative risk 1.40 [1.23-1.59]). No important differences in other outcomes or side-effects were noted; however, urine production was significantly lower on day 1 and concentration of creatinine in serum was significantly higher on day 3 after ibuprofen. INTERPRETATION:Ibuprofen prophylaxis in preterm infants does not reduce the frequency of intraventricular haemorrhage, but does decrease occurrence of patent ductus arteriosus.
RCT Entities:
BACKGROUND:Ibuprofen is used for treatment and prevention of patent ductus arteriosus in low-birthweight infants. Its effects on regional circulations differ from those of indometacin. Because prophylactic indometacin reduces the frequency of severe intraventricular haemorrhage and patent ductus arteriosus, we aimed to study the efficacy of early ibuprofen in reducing these outcomes in a double-blind, multicentre trial. METHODS: Within 6 h after birth, 415 low-birthweight infants (gestational age <31 weeks) were randomly allocated ibuprofen-lysine (10 mg/kg then two doses of 5 mg/kg after 24 h and 48 h) or placebo intravenously. The primary outcome was occurrence of severe intraventricular haemorrhage; secondary outcomes were occurrence of patent ductus arteriosus and possible adverse effects of ibuprofen. Analysis was by intention to treat. FINDINGS: 17 (8%) of 205 infants assigned ibuprofen and 18 (9%) of 210 assigned placebo developed severe intraventricular haemorrhage (relative risk 0.97 [95% CI 0.51-1.82]). In 172 (84%) infants of the ibuprofen group, the ductus was closed on day 3 compared with 126 (60%) of the placebo group (relative risk 1.40 [1.23-1.59]). No important differences in other outcomes or side-effects were noted; however, urine production was significantly lower on day 1 and concentration of creatinine in serum was significantly higher on day 3 after ibuprofen. INTERPRETATION:Ibuprofen prophylaxis in preterm infants does not reduce the frequency of intraventricular haemorrhage, but does decrease occurrence of patent ductus arteriosus.
Authors: Karel Allegaert; Veerle Cossey; Anne Debeer; Jean Paul Langhendries; Bart Van Overmeire; Jan de Hoon; Hugo Devlieger Journal: Pediatr Nephrol Date: 2005-03-23 Impact factor: 3.714
Authors: Katrin Echtler; Konstantin Stark; Michael Lorenz; Sandra Kerstan; Axel Walch; Luise Jennen; Martina Rudelius; Stefan Seidl; Elisabeth Kremmer; Nikla R Emambokus; Marie-Luise von Bruehl; Jon Frampton; Berend Isermann; Orsolya Genzel-Boroviczény; Christian Schreiber; Julinda Mehilli; Adnan Kastrati; Markus Schwaiger; Ramesh A Shivdasani; Steffen Massberg Journal: Nat Med Date: 2009-12-06 Impact factor: 53.440
Authors: Anna Maria Hibbs; Dennis Black; Lisa Palermo; Avital Cnaan; Xianqun Luan; William E Truog; Michele C Walsh; Roberta A Ballard Journal: J Pediatr Date: 2009-12-06 Impact factor: 4.406