LAUSR

Objective The study aimed to investigate, whether expectant management is non-inferior to early patent ductus arteriosus (PDA) treatment with regard to the composite of mortality and/or incidence of bronchopulmonary dysplasia (BPD) in very preterm infants. Study design 208 very preterm infants of the gestational age <32 weeks, birth weight <1500 g, chronological age <72 h, and PDA >1.5 mm were randomized between the treatment or expectant management group. Both, the intention-to-treat and per-protocol analyses were performed. Results 104 (50%) patients received rectal ibuprofen (n=52) or intravenous acetaminophen (n=52) within first 72 h of life. In 104 (50%) infants expectant management was used. Eight of them (8%) received rescue treatment at the median age of 7 (6-13) days. PDA closure rates by the 10th day of life were 81% (n=84) in the treatment arm, and 58% (n=60) in the expectant management arm (p<0.01). The median age at the time of ductus closure was 5 (5-6) days in the treatment arm, and 8 (6-11) days in the expectant management arm (p<0.01). At the time of discharge, ductus was closed in 83% of treated infants and in 78% of patients who were managed expectantly (p>0.05). No significant difference between the groups was found for the primary clinical outcomes, BPD/death, or the secondary outcomes at a postmenstrual age of 36 weeks or discharge. Conclusion Expectant management is non-inferior to early PDA treatment for reducing the incidence of death/BPD. Compared with the expectant management, early pharmacological treatment provides more frequent and faster PDA closure in preterm infants with gestational age <32 weeks, but neither reduces morbidity nor improves survival rates.