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Randomized Trial to Compare Renal Function and Ductal Response between Indomethacin and Ibuprofen Treatment in
Yuh Jyh Lin1, Chung Ming Chen, Virender K Rehan
1Department of Pediatrics, National Cheng-Kung University, Tainan, Taiwan, ROC.
Insights
Ibuprofen showed fewer renal side effects than indomethacin in extremely low birth weight (ELBW) infants, but indomethacin was more effective in closing the patent ductus arteriosus. Further research is needed on prostaglandin
Area of Science:
- Neonatalogy
- Pharmacology
- Pediatric Nephrology
Background:
- Head-to-head comparisons of indomethacin and ibuprofen for renal function and ductal response in extremely low birth weight (ELBW) infants are infrequent.
- Patent ductus arteriosus (PDA) is a common complication in ELBW infants, often requiring medical intervention.
Purpose of the Study:
- To compare the efficacy and safety of indomethacin versus ibuprofen in treating hemodynamically significant PDA in ELBW infants.
- To assess the impact of these treatments on renal function and ductal closure rates.
Main Methods:
- A double-blind, randomized controlled trial involving 144 ELBW infants with significant PDA.
- Infants received either indomethacin (0.2, 0.1, 0.1 mg/kg IV) or ibuprofen lysine (10, 5, 5 mg/kg IV) over three days.
- Renal function (urine output, creatinine, GFR) and ductal response were monitored.
Main Results:
- Ibuprofen group had significantly less decreased urine output (21% vs 41%, p=0.02).
- Indomethacin group had a higher rate of persistent ductal response (66% vs 49%, p=0.046) but worse renal function markers (lower GFR, higher creatinine).
- Mortality and major morbidities were comparable between groups.
Conclusions:
- Ibuprofen demonstrates a better renal safety profile compared to indomethacin in ELBW infants with PDA.
- Indomethacin appears more effective for ductal closure, despite increased renal risks.
- The role of prostaglandins in renal tubular function in ELBW infants requires further investigation.
Background:
A head to head comparison study on renal function and ductal response between indomethacin and ibuprofen has rarely been conducted in extremely low birth weight (ELBW) infants.
Objectives:
The aim was to compare renal function and ductal response between indomethacin and ibuprofen in ELBW infants.
Methods:
We performed a double-blind randomized control trial to compare renal function and ductal response between indomethacin (0.2, 0.1, and 0.1 mg/kg i.v. every 24 h for 3 doses) and ibuprofen lysine (10, 5, and 5 mg/kg i.v. every 24 h for 3 doses) in ELBW infants with significant hemodynamic patent ductus arteriosus (cardiovascular dysfunction score >3 and LA/AO ratio ≥1.3).
Results:
A total of 144 infants were enrolled: 73 received indomethacin and 71 received ibuprofen lysine. Significant decreases in urine output were seen in 30 infants (41%) in the indomethacin group and 15 (21%) in the ibuprofen group (p = 0.02). The indomethacin group was associated with a significantly higher chance of persistent ductal response than the ibuprofen group (66 vs. 49%, p = 0.046), but with a lower glomerular filtration rate on day 1, higher serum creatinine on days 1, 2, and 7, and lower urinary prostaglandin on days 2-7. Both groups were comparable in mortality and in bronchopulmonary dysplasia, intraventricular hemorrhage, necrotizing enterocolitis, and retinopathy of prematurity morbidity.
Conclusions:
With the current dosage, ibuprofen had fewer renal side effects but was associated with a lower rate of persistent ductal closure in ELBW infants. The precise role of prostaglandin on renal tubular function in ELBW infants remains to be further investigated.
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