Treatment of patent ductus arteriosus (PDA) using ibuprofen: renal side-effects in VLBW and ELBW newborns.
OBJECTIVE
This study aims to determine whether or not treatment of preterm neonates with PDA using IV ibuprofen can impair renal function and in what range of birth weights and gestational ages the risk of major renal side-effects due to ibuprofen is highest.


METHODS
134 preterm newborns with PDA were enrolled and randomized to receive either placebo or a 3-day-course (10, 5 and 5 mg/kg) of IV ibuprofen. 67 newborns (mGA: 27(+3) w and mBW: 989 g) with PDA received ibuprofen.


RESULTS
Subdividing the infants according to BW and to GA, the values of creatinine and BUN were only significantly higher than initial values at the end of the therapy in newborns with a BW ≤1000 g and/or GA ≤26 weeks. Renal impairment is greater the lower the weight and gestational age of the infant at birth.


CONCLUSIONS
Ibuprofen significantly impairs renal function in preterm infants with a GA ≤26 weeks and/or in ELBW neonates, while it may be considered safe for infants with a BW >1000 g and/or GA >26 weeks. Thus, before starting therapy with IV ibuprofen, it is essential to take into account the BW and GA of newborns and the effective need for treatment from the point of view of the ratio of risks to benefits, due to its substantial renal side-effects.
Department of Pediatrics, Obstetrics and Reproductive Medicine, Neonatal Intensive Care, University of Siena, Siena, Italy.
Franco
F
Bagnoli
Annalisa
A
Rossetti
Gabriele
G
Messina
Annalisa
A
Mori
Martina
M
Casucci
Barbara
B
Tomasini
D001724:Birth Weight; D001806:Blood Urea Nitrogen; D003404:Creatinine / Q000097:blood; D016861:Cyclooxygenase Inhibitors; D004374:Ductus Arteriosus, Patent / Q000188:drug therapy*; D005260:Female; D005865:Gestational Age; D005919:Glomerular Filtration Rate; D006801:Humans; D007052:Ibuprofen / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D052577:Infant, Extremely Low Birth Weight; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000139:chemically induced / Q000188:drug therapy; D019102:Infant, Very Low Birth Weight; D007674:Kidney Diseases / Q000139:chemically induced*; D008297:Male; D010919:Placebos; D012307:Risk Factors
D016861:Cyclooxygenase Inhibitors; D010919:Placebos; D003404:Creatinine; D007052:Ibuprofen