Key result
Ibuprofen raises GI bleeding risk ~99% vs placebo in preterm neonates with PDA.
Why the study?
Adverse events associated with ibuprofen use for PDA closure in preterm neonates were not comprehensively identified or quantified across studies.
Does ibuprofen increase the risk of gastrointestinal bleeding and renal adverse events compared to placebo, paracetamol, or indomethacin in preterm neonates with PDA?
Meta-Analysis
Does ibuprofen increase the risk of gastrointestinal bleeding and renal adverse events compared to placebo, paracetamol, or indomethacin in preterm neonates with PDA?
Relative Risk: 1.99 (95% CI 1.13–3.5)
In preterm neonates with PDA, ibuprofen increases the risk of GI bleeding compared to paracetamol and placebo, but has a lower risk of oliguria compared to indomethacin.
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Quantified AE risks (oliguria ~8/100, GI bleed ~9/100) support renal/GI monitoring and paracetamol preference in preterm PDA; confirms prior RCT signals across broader evidence.
Al-Turkait et al. (2019) conducted a meta-analysis in Patent ductus arteriosus (PDA). Ibuprofen vs. Placebo, paracetamol, or indomethacin was evaluated on Gastrointestinal (GI) bleeding (ibuprofen vs placebo) (RR 1.99, 95% CI 1.13-3.50). In preterm neonates with PDA, ibuprofen was associated with a significantly increased risk of gastrointestinal bleeding compared to placebo (RR 1.99; 95% CI 1.13-3.50).
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