This controlled, double-blind, study assessed the renal impact of early (< 12 hr postnatal age) indomethacin [I], for prevention of patent ductus arteriosus (PDA), in O2 dependent inborn infants with birth weights (BW)≤1300 gm. Fifty infants randomly received 3 IV doses of [I] or placebo [P] at 12 hr intervals. Dose1 (D1) was 0.2 mg/kg;D2 and D3 were 0.1 mg/kg each. Fluid balance, serum sodium (Na), potassium (K), creatinine (Cr), blood urea nitrogen (BUN) and fractional Na excretion (FENa) were evaluated pre-D1, 6-12 hr post-D1, 12-36 hr post-D3, and 1 wk post-D3. Timed urine specimens were used to derive Cr clearance (CCr) post-D3 and 1 wk post-D3. The 25 infants in each group were comparable in BW, gestational age, APGARs, pH and base excess at study entry. [I]-treated infants had reduced urine output (UO) in the 12 hr period following D1 that was no longer evident post-D3. Fluid intake, Na, K, BUN, Cr, FENa, and CCF were similar throughout the study. Renal data (x±SEM) revealed:

In contrast to reports of renal dysfunction induced by indomethacin therapy for symptomatic PDA, early [I] appears to alter renal function minimally in prematures without significant PDA.

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