Objectives: 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.