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Treatment of persistent patent ductus arteriosus in preterm infants: time to accept the null hypothesis?
1Division of Neonatal and Developmental Medicine, Department of Pediatrics, Stanford University School of Medicine, Palo Alto, CA 94304-1510, USA. benitzwe@stanford.edu
Insights
Evidence does not support closing the patent ductus arteriosus in preterm infants. Current treatments may be harmful, and further research with novel strategies is needed.
Area of Science:
- Neonatal Medicine
- Pediatric Cardiology
Background:
- Patent ductus arteriosus (PDA) is common in preterm infants.
- Medical and surgical interventions are standard but lack robust evidence.
- Emerging data suggests potential harm from PDA closure treatments.
Purpose of the Study:
- To review the history and evidence for PDA closure interventions in preterm infants.
- To critically evaluate the benefits and risks of current PDA treatments.
- To determine the justification for continued routine use and similar clinical trials.
Main Methods:
- Systematic review of individual trials.
- Meta-analysis of pooled randomized-controlled trial data.
- Critical examination of immediate treatment consequences.
Main Results:
- No evidence supports the benefit of medical or surgical PDA closure in preterm infants.
- Existing trials and pooled data do not demonstrate efficacy.
- Immediate consequences of treatment do not indicate benefit.
Conclusions:
- Current evidence is insufficient to justify routine medical or surgical PDA closure.
- Further clinical trials with similar designs are not warranted.
- A definitive trial comparing standard care with novel, non-closure strategies is proposed.
Abstract:
Medical and surgical interventions are widely used to close a persistently patent ductus arteriosus in preterm infants. Objective evidence to support these practices is lacking, causing some to question their usage. Emerging evidence suggests that treatments that close the patent ductus may be detrimental. This review examines the history of and evidence underlying these treatments. Neither individual trials, pooled data from groups of randomized-controlled trials, nor critical examination of the immediate consequences of treatment provide evidence that medical or surgical closure of the ductus is beneficial in preterm infants. These conclusions are supported by sufficient evidence. Neither continued routine use of these treatments nor additional clinical trials using similar designs seems to be justified. A definitive trial, comparing current standard management with novel strategies not primarily intended to achieve ductal closure, may be necessary to resolve doubts regarding the quality or conduct of prior studies.
