Mandatory Closure versus Nonintervention

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A comment from Prof Samir Gupta

Chief Investigator for the Baby-OSCAR Trial

This retrospective cohort study compared two time periods of different approaches to PDA. In period I, all large PDA (more than 2 mm) were closed medically at a median age of 7 days and/or surgically at a median age of 12 days. In period II no treatment was offered.

The data suggests once PDA is symptomatic, it does not affect outcomes whether one closes a PDA or not. Investigators report higher incidence of BPD in period I when PDA was closed surgically (in ~80% babies). This could be the effect of surgery as this association has been reported earlier. It is surprising that, unlike previous reports, persistent PDA in this study was not associated with increased odds of death or NEC, but with significantly less BPD. The medication used in this study was indomethacin that is now known to have a poor side effect profile as compared to ibuprofen. The limitations of this study are that it is a single site, retrospective observational study in two time periods and uses indomethacin for medical treatment.

The results of this study, however, support the Baby-OSCAR protocol that a symptomatic PDA, if diagnosed after 7 days of age in ventilator dependent babies, does not necessarily benefit from medical and/or surgical treatment, and hence by limiting rescue or open-label treatment, we do not cause harm.

Mandatory Closure Versus Nonintervention for Patent Ductus Arteriosus in Very Preterm Infants

Se In Sung, MD*, Yun Sil Chang, MD*, Ji Young Chun, MD, Shin Ae Yoon, MD, Hye Soo Yoo, MD, So Yoon Ahn, MD, and Won Soon Park, MD 

(2016, The Journal of Pediatrics)

DOI:10.1016/j.jpeds.2016.06.046

Updated: Thursday, 16 March 2017 14:06 (v4)