A post hoc appraisal of the PDA RCT to assess the relationship between early patent ductus arteriosus (PDA) shunt elimination and chronic lung disease or death (CLD/Death).
Infants <29 weeks were divided into four groups: intervention arm in whom PDA closure was achieved (n = 17); intervention arm in whom PDA closure was not achieved (n = 13); placebo arm (n = 30); low risk infants (n = 13). The main outcome measure was CLD/Death.
The rates of CLD/Death were lower in the Intervention Success Group (29%) when compared to the Intervention Failure Group (85%) or the Placebo Group (60%, all p < 0.05). There was no difference in CLD/Death between the Intervention Success and Low Risk Groups (8%, p > 0.05). A persistent PDA beyond Day 8 was associated with CLD/Death (aOR 6.5 [1.7–25.5]).
Early shunt elimination in preterm infants with a PDA may reduce respiratory morbidity when compared to infants with prolonged shunt exposure.
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This study was funded by a research grant from the Temple Street Hospital Foundation (Ref: RPAC 16-03). The National Children’s Research Centre funded Ph.D. fees associated with this project.
Conflict of interest
The authors declare no competing interest.
Ethical approval and consent to participate
Ethical approval was obtained from our institutional ethics board (The National Maternity Hospital, Reference Number: EC 09.2016) and written informed consent was obtained from all parents. The study was performed in accordance with the Declaration of Helsinki.
Publisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
Trial Registration: The trial was registered with the ISRCTN (13281214) and the European Union Drug Regulating Authorities Clinical Trials Database (2015-004526-33).
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Bussmann, N., Smith, A., Breatnach, C.R. et al. Patent ductus arteriosus shunt elimination results in a reduction in adverse outcomes: a post hoc analysis of the PDA RCT cohort. J Perinatol 41, 1134–1141 (2021). https://doi.org/10.1038/s41372-021-01002-z
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