Abstract
Background: Recognizing a change in serum creatinine concentrations is useful to detect a renal adverse drug reaction signal. Assessing and characterizing the nephrotoxic side-effects of drugs in extremely low birth weight (ELBW, ≤1000 g) neonates remain challenging due to the high variability in creatinine in this population. This study aims to investigate and quantify the impact of ibuprofen treatment on kidney function, reflected by serum creatinine. Method: A recently developed dynamical model for serum creatinine was used to simulate creatinine profiles for typical, reference ELBW neonates with varying gestational and postnatal ages whilst being exposed to ibuprofen treatment. Results: The increase of serum creatinine concentrations due to ibuprofen treatment is most apparent during the first week of life. The difference in serum creatinine values between ibuprofen-exposed vs. non-exposed neonates decreases with increasing postnatal age, independent of gestational age. Conclusion: The difference in serum creatinine concentrations between ibuprofen-exposed vs. non-exposed neonates decreases with postnatal age, indicating an increased clearing capacity and resulting in a weak ibuprofen-related adverse drug reaction signal beyond early neonatal life.
Highlights
Low birth weight (ELBW, ≤1,000 g) infants are born during active nephrogenesis, making their kidneys extremely vulnerable to damage by external factors such as exposure to nephrotoxic drugs or diseases such as neonatal sepsis
The increase of serum creatinine concentrations due to ibuprofen treatment is most apparent during the first week of life
The difference in serum creatinine values between ibuprofen-exposed vs. non-exposed neonates decreases with increasing postnatal age, independent of gestational age
Summary
Low birth weight (ELBW, ≤1,000 g) infants are born during active nephrogenesis, making their kidneys extremely vulnerable to damage by external factors such as exposure to nephrotoxic drugs or diseases such as neonatal sepsis. The variations in serum creatinine values in these extreme preterm infants are still not fully understood and the accurate assessment of kidney function remains challenging. Developed equations such as the (bedside) Schwartz formula support clinicians in estimating the glomerular filtration rate (GFR), the underlying physiology and the impact of pharmacotherapy have not been fully elucidated for ELBW neonates (Schwartz et al, 1976; Schwartz et al, 2009). The quantitative effect of maturational changes such as gestational age and postnatal age, together with the impact of mode of delivery and ibuprofen treatment on the serum creatinine in ELBW neonates, has been reported (van Donge et al, 2020). This study aims to investigate and quantify the impact of ibuprofen treatment on kidney function, reflected by serum creatinine
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