Table 1 Characteristics of the included studies
Study | Country (Centers) | Population | Intervention | Control | Primary outcome | Sample size (control) | GA < 26 weeks (%) | Mean or median GA | Open- label rate in control | PDA closed | |
|---|---|---|---|---|---|---|---|---|---|---|---|
Intervention group | Control group | ||||||||||
De Waal 2021 | Australia (2) | GA < 29 weeks Postnatal age <72 h PDA diameter >1.5 mm and predominant left-to- right shunting | Ibuprofen (iv) or indomethacin (iv) | Placebo | Recruitment rate and rate of open-label treatment. | 72 (37) | NA | 26.4 | 1/37 (2.7%) | 26/35 (74.3%)b | 11/37 (29.7%)b |
Hundscheid 2022 BeNeDuctus | The Netherlands, Belgium and Denmark (17) | GA < 28 weeks Postnatal age 24-72 h, PDA diameter >1.5 mm and predominant left-to- right shunting | Ibuprofen (iv) | Expectant (unmasked) | Death or BPD or NEC ≥ 2 | 273 (136) | 119 (43.6%) | 26.1 | 1/136 (0.7%) | 95/132 (72.0%)c | NA |
Potsiurko 2022 | Ukraine (1) | GA < 32 weeks and birth weigth <1500 g, Postnatal age <72 h, PDA diameter >1.5 mm | Ibuprofen (pr) or acetaminophen (iv) | Expectant (unmasked) | Death or BPD | 208 (104) | 36 (17.3%) | 28.0 | 8/104 (7.7%) | 84/104 (80.8%)d | 60/104 (57.7%)d |
Sung 2020 | Korea (1) | GA < 31 weeks Postnatal age 6-14 days, PDA diameter >1.5 mm and predominant left-to- right shunting | Ibuprofen (po) | Placebo | Death or BPD | 142 (72) | 80 (56.3%) | 26.8 | 0/72 (0%) | 14/70 (20.0%)e | 3/72 (4.2%)e |
Gupta 2024 Baby-OSCAR | United Kingdom (32) | GA < 29 weeks, PDA diameter >1.5 mm and unrestricted left-to- right shunting. | Ibuprofen sodium (iv) | Placebo | Death or BPD | 646 (322) 598 (289)a | 302 (46.7) | 26.1 | 82/322 (25.5%) 63/289 (21.8%)a | 176/317 (55.5%)f | 117/316 (37.0%)f |
