Abstract
Objective The study aimed to investigate, whether expectant management is noninferior 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 A total of 208 very preterm infants of the gestational age <32 weeks, birth weight
<1,500 g, chronological age <72 hours, and PDA >1.5 mm were randomized between the
treatment or expectant management groups. Both, the intention-to-treat and per-protocol
analyses were performed.
Results A total of 104 (50%) patients received rectal ibuprofen (n = 52) or intravenous acetaminophen (n = 52) within first 72 hours of life. In 104 (50%) infants, expectant management was
used. Eight of them (8%) received rescue treatment at the median age of 7 (range:
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 (range: 5–6) days in
the treatment arm and 8 (range: 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 noninferior 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 it neither reduces morbidity nor improves survival rates.
Key Points
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PDA persistence in very preterm infants is associated with an increased risk of BPD/death.
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PDA treatment accelerates ductus closure, but does not improve survival or reduce
severe neonatal morbidity.
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Expectant management is not associated with a higher risk of BPD/death.
Keywords
patent ductus arteriosus - early PDA treatment - noninferior - expectant management
- perinatal outcomes
