Research Article
Volume 10 Issue 12 - 2021
Evidence on the Effectiveness and Safety of Pharmacological Treatment for the Patent Ductus Arteriosus in Premature Newborns
Augusto Sola1*, Marcelo Cardetti2 and Susana Rodríguez3
1General Director, Iberoamerican Society of Neonatology (SIBEN), USA
2Council Board, Iberoamerican Society of Neonatology (SIBEN), San Luis, Argentina
3Scientific Director, Iberoamerican Society of Neonatology (SIBEN), Research and Educational Department, Garrahan Hospital, Buenos Aires, Argentina
*Corresponding Author: Augusto Sola, General Director, Iberoamerican Society of Neonatology (SIBEN), USA.
Received: November 24, 2021; Published: November 30, 2021


Background: Patent ductus arteriosus (PDA) is the most common cardiovascular problem in preterm infants; evidence regarding the best treatment approach is lacking. Currently available medical options to treat a PDA include Indomethacin (INDO), Ibuprofen (IBU) and Acetaminophen or Paracetamol (PARA) and wide variation exists in the pharmacological clinical approach for PDA closure. The purpose of this commentary is to raise nonjudgmental awareness of current evidence on effectiveness and known or potential adverse effects when a clinical decision for pharmacological treatment has already been made.

Objectives: To identify the current evidence on effectiveness and safety of the pharmacological treatment of PDA in premature newborns, describe potential risks of the drugs utilized for ductal closure and present data from 813 preterm infants who were treated for PDA and reported to SIBEN’s network.

Methods: Identify and dissect the most recent evidence published on effectiveness and safety on the three drugs currently used for PDA closure and analyze three years of data at SIBEN’s network on preterm infants who received pharmacological treatment for a PDA. Statistics include Chi2 and Fisher's exact test.

Results: Effectiveness and safety of INDO, IBU and PARA for ductal closure in preterm infants reveal some differences which are detailed in the manuscript. To date, oral IBU at high dose seems to be an effective and safe treatment for PDA closure, and INDO maybe just as good. There is still a need for appropriate pharmacodynamic and follow-up studies examining both the route and dose of PARA, before it can be concluded that PARA is an effective and safe drug for PDA closure. Data from the 813 preterm infants < 1,500 grams at SIBEN’s network who received pharmacological treatment for a PDA showed increased morbidity in the PARA group.

Conclusion: As with many of the treatments in the neonatal period, our duty is “first do no harm” and the risk benefit ratio should always be kept in mind when caring for fragile neonates. The most effective therapeutic medications with better known safety profiles based on current evidence should be the ones to be used.

Keywords: Patent Ductus Arteriosus; Preterm Infants; Indomethacin; Ibuprofen; Acetaminophen


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Citation: Augusto Sola., et al. “Evidence on the Effectiveness and Safety of Pharmacological Treatment for the Patent Ductus Arteriosus in Premature Newborns”. EC Paediatrics 10.12 (2021): 120-131.

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