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Rozé JC, Cambonie G, Le Thuaut A, Debillon T, Ligi I, Gascoin G, Patkai J, Beuchee A, Favrais G, Flamant C, Durrmeyer X, Clyman R. Effect of Early Targeted Treatment of Ductus Arteriosus with Ibuprofen on Survival Without Cerebral Palsy at 2 years in Infants with Extreme Prematurity: A Randomized Clinical Trial. J Pediatr. 2020 Dec 8:S0022-3476(20)31488-8. doi: 10.1016/j.jpeds.2020.12.008. Epub ahead of print. PMID: 33307111.

Objective: To examine the effects of early echocardiography-targeted ibuprofen treatment of large patent ductus arteriosus (PDA) on survival without cerebral palsy (CP) at 24 months corrected age.

Study design: We enrolled infants born at <28 weeks of gestation with a large PDA on echocardiography at 6-12 hours after birth to ibuprofen or placebo by 12 hours of age in a multicenter, double blind, randomized-controlled trial. Open-label ibuprofen was allowed for prespecified criteria of a hemodynamically significant PDA. The primary outcome was survival without CP at 24 months corrected age.

Results: Among 337 enrolled infants, 109 had a small or closed ductus and constituted a reference group; 228 had a large PDA and were randomized. The primary outcome was assessed at 2 years in 108/114 (94.7%) and 102/114 (89.5%) patients allocated to ibuprofen or placebo, respectively. Survival without CP occurred in 77/108 (71.3%) after ibuprofen, 73/102 (71.6%) after placebo (adjusted relative risk (aRR), 0.98, 95% confidence interval (CI) 0.83 to 1.16, P=.83), and 77/101 (76.2%) in reference group. Ibuprofen-treated infants had a lower incidence of PDA at day 3. Severe pulmonary hemorrhage during the first 3 days occurred in 2/114 (1.8%) ibuprofen and 9/114 (7.9%) placebo-treated infants (aRR, 0.22, 95% CI, 0.05 to 1.00, P=.05). Open-label rescue treatment with ibuprofen occurred in 62.3% placebo and 17.5% ibuprofen-treated infants (P<.001), at a median (IQR) age of 4 (3,5) and 4 (4,12) days, respectively.

Conclusion: Early echocardiography-targeted ibuprofen treatment of a large PDA did not change the rate of survival without CP.

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