Abstract
Context: There is an ongoing debate on the optimal management of patent ductus arteriosus (PDA) in preterm infants. Identifying subgroup of infants who would benefit from pharmacological treatment might help.Objective: To investigate the modulating effect of the differences in methodological quality, the rate of open-label treatment, and patient characteristics on relevant outcome measures in randomized controlled trials (RCTs).Data Sources: Electronic database search between 1950 and May 2020.Study Selection: RCTs that assessed pharmacological treatment compared to placebo/no treatment.Data Extraction: Data is extracted following the PRISMA guidelines. Outcome measures were failure to ductal closure, surgical ligation, incidence of necrotizing enterocolitis, bronchopulmonary dysplasia, sepsis, periventricular leukomalacia, intraventricular hemorrhage (IVH) grade ≥3, retinopathy of prematurity and mortality.Results: Forty-seven studies were eligible. The incidence of IVH grade ≥3 was lower in the treated infants compared to the placebo/no treatment (RR 0.77, 95% CI 0.64–0.94) and in the subgroups of infants with either a gestational age <28 weeks (RR 0.77, 95% CI 0.61–0.98), a birth weight <1,000 g (RR 0.77, 95% CI 0.61–0.97), or if untargeted treatment with indomethacin was started <24 h after birth (RR 0.70, 95% CI 0.54–0.90).Limitations: Statistical heterogeneity caused by missing data and variable definitions of outcome parameters.Conclusions: Although the quality of evidence is low, this meta-analysis suggests that pharmacological treatment of PDA reduces severe IVH in extremely preterm, extremely low birth weight infants or if treatment with indomethacin was started <24 h after birth. No other beneficial effects of pharmacological treatment were found.
Highlights
Patent ductus arteriosus (PDA) is common in preterm and very low birth weight infants [1]
We found no significant reduction of major clinical outcomes, not even in the subgroup of randomized controlled trails (RCTs) with low openlabel treatment rates in the no treatment group of patients
Important data on long-term consequences of neurodevelopmental impairment are lacking for these studies
Summary
Patent ductus arteriosus (PDA) is common in preterm and very low birth weight infants [1]. A uniform definition of a hemodynamic significant PDA does not exist, nor is there clear evidence in favor of or against many of the approaches to treating PDA [7,8,9]. A recent meta-analysis, showed that neither shortterm nor long-term outcomes seem to differ between treated and untreated patients [11]. This sparked an ongoing debate on the optimal approach to treating PDA, which ranges from expectant management to aggressive treatment with a variety of cyclooxygenase inhibitors or acetaminophen with varying doses and at different intervals [5]. The results of randomized controlled trails (RCTs) on PDA treatment have been reviewed extensively, only a small number of reviews stratified the results according to infant characteristics, methodological quality [11, 12], timing of treatment [12], or to the definitions of a hemodynamic significant PDA [9]
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