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Patent ductus arteriosus shunt elimination results in a reduction in adverse outcomes: a post hoc analysis of the PDA RCT cohort

Journal of Perinatology volume 41, pages 1134–1141 (2021)Cite this article

Subjects

Abstract

Objective

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).

Study design

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.

Results

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]).

Conclusions

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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Fig. 1: Patent ductus arteriosus characteristics between infants with an open duct beyond day 8 (red line) and infants with a closed duct by day 8 (blue line).

Availability of data and materials

Data will be kept confidential in compliance with the European General Data Protection Regulation.

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Funding

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.

Author information

Authors and Affiliations

  1. Department of Neonatology, The Rotunda Hospital, Dublin, Ireland

    Neidín Bussmann, Aisling Smith, Colm R. Breatnach, Naomi McCallion & Afif EL-Khuffash

  2. Department of Paediatrics, The Royal College of Surgeons in Ireland, Dublin, Ireland

    Naomi McCallion & Afif EL-Khuffash

  3. Department of Pharmacy, The Rotunda Hospital, Dublin, Ireland

    Brian Cleary

  4. School of Pharmacy, Royal College of Surgeons in Ireland, Dublin, Ireland

    Brian Cleary

  5. Department of Paediatric Cardiology, Our Lady’s Children’s Hospital Crumlin, Dublin, Ireland

    Orla Franklin

  6. Division of Neonatology, Stead Family Children’s Hospital, Iowa City, IA, USA

    Patrick J. McNamara

  7. Departments of Pediatrics and Cardiology, University of Iowa, Iowa City, IA, USA

    Patrick J. McNamara

  8. Cardiology, University of Iowa, Iowa City, IA, USA

    Patrick J. McNamara

Authors
  1. Neidín Bussmann
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  2. Aisling Smith
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  4. Naomi McCallion
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  6. Orla Franklin
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  7. Patrick J. McNamara
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  8. Afif EL-Khuffash
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Contributions

AEL-K and PMcN devised the study protocol and analysis plan, which was approved by all the authors, and provided oversight for the conduct of the trial. NB recruited the patients, performed the blinded echocardiography analysis and data collection. CB and AS assisted in patient recruitment and echocardiography studies. NMcC provided expert neonatal oversight. BC provided oversight of drug preparation and administration. OF provided cardiology expertise. All the listed authors made substantial contributions to either the conception or design of the work, or the acquisition, analysis, or interpretation of data for the work. NB wrote the first draft but all the listed authors revised it critically for important intellectual content, approve the final version of the manuscript and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Corresponding author

Correspondence to Afif EL-Khuffash.

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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.

Additional information

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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