Efficacy Ibuprofen for the prevention of patent ductus arteriosus in preterm and/or low birth weight infants

Systematic review found prophylactic ibuprofen (IV or oral) decreased the risk of PDA on day 3 or 4 (RR 0.39, 95% CI 0.31 to 0.48; NNTB 4, 95% CI 3 to 5; 9 trials; N = 1029), although in the control group, the spontaneous closure rate was 58% by day 3 to 4 of age. Ibuprofen decreased the need for rescue treatment with cyclo-oxygenase inhibitors (RR 0.17, 95% CI 0.11 to 0.26; NNTB 4; 95% CI 3 to 5), and need for surgical ductal ligation (RR 0.46, 95% CI 0.22 to 0.96; NNTB 33, 95% CI 20 to infinity; 7 trials; N = 925). Prophylactic ibuprofen decreased grade 3 or 4 IVH in infants (RR 0.67, 95% CI 0.45 to 1.00; 7 trials; N = 925), and increased risk of oliguria (RR 1.45, 95% CI 1.04 to 2.02; NNTH 17, 95% CI 9 to 100; 4 trials; N = 747). [5]

For the comparison prophylactic ibuprofen versus indomethacin, only one study has been published that used oral treatment, and results were reported in 62 infants. There were no significant results apart from a significant increase in length of hospitalisation for the ibuprofen group. [21]

Conclusion: Prophylactic use of ibuprofen decreases the incidence of PDA, need for rescue treatment with cyclo-oxygenase inhibitors and surgical ductal closure. Adverse effects associated with ibuprofen (IV or oral) included increased risks for oliguria, increase in serum creatinine levels, and increased risk of gastrointestinal haemorrhage. There was a reduced risk for intraventricular haemorrhage (grade III - IV) but no evidence of a difference in mortality, chronic lung disease, necrotising enterocolitis, or time to reach full feeds. In the control group, the patent ductus arteriosus had closed spontaneously by day 3 or 4 in 58% of neonates. Prophylactic treatment exposes a large proportion of infants unnecessarily to a drug that has important side effects without conferring any important short-term benefits. Current evidence does not support the use of ibuprofen for prevention of patent ductus arteriosus. [5] [LOE I GOR B]