Editorial
Patent Ductus Arteriosus: Evidence for and against Treatment

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Prophylactic trials

Morbidities affected by the PDA (or its treatment) that could be detected in prophylactic trials are those that occur between birth and the time of backup treatment (2-3 days after birth) (Figure). Both, the individual prophylactic trials and a meta-analysis of their results (reviewed in references 9 and 10) consistently show that prophylactic use of indomethacin increases the effectiveness of pharmacologic closure and decreases the need for surgical ligation, decreases the incidence of early,

Symptomatic treatment trials

Like the prophylactic trials, the symptomatic treatment trials can only detect PDA-related morbidities that occur between the time of initial treatment (>2 days after birth) and the time of backup closure (Figure). In these trials, infants were exposed to a symptomatic PDA for varying time spans before backup closure was invoked (mean [range] = 5 [1-14] days). For the purposes of discussion, we analyzed only those trials that waited at least 6 days (mean = 9 ± 3 days) before resorting to backup

Pulmonary morbidity

Five of the seven trials that reported pulmonary morbidity8, 12, 13, 14, 15, 16, 17 (and a meta-analysis of the seven trials) showed that exposure to a symptomatic PDA, for at least 6 days, prolonged the need for supplemental oxygen and/or mechanical ventilation. Information about longer exposures to a PDA can be found in studies of preterm baboons. These studies provide evidence for more long lasting pulmonary morbidity following exposure to a persistent PDA. Premature newborn baboons, exposed

Necrotizing enterocolitis

There is little evidence to support or refute the role of a PDA in necrotizing enterocolitis (NEC). A meta-analysis of the trials8, 13, 15, 16, 18 that delayed backup treatment for at least 6 days showed that early treatment of a PDA may decrease the incidence of NEC, but only among infants <1000 g birth weight. This analysis has some uncertainty because it is heavily weighted by a single study18; no significant association between a PDA and NEC was found when this study was removed from the

Retinopathy of prematurity (ROP)

No causal role has been found for a PDA in ROP.

Morbidities associated with indomethacin

Any discussion of PDA treatment must consider the possibility of treatment-related morbidities. Although none of the treatment trials were specifically designed to examine the incidence of morbidities caused by indomethacin or surgery, the prophylactic treatment trials do provide some information about those associated with indomethacin. In these trials, <50% of control group infants were exposed to indomethacin (compared with 100% in the prophylactic group) (see reference 9). Therefore, one

Morbidities associated with ligation

What happens when pharmacologic treatment fails to close the PDA? Surgical ligation of a PDA is associated with its own set of morbidities: thoracotomy, pneumothorax, chylothorax, infection, and vocal cord paralysis. More than 50% of infants with birth weights ≤1000 g will require inotropic support for profound hypotension during the postoperative period.30 In addition, neonatal transport to another facility may be required if surgical expertise is not readily available. The article by Kabra et

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    Supported by grants from U.S. Public Health Service (NIH grants HL46691, HL56061) and by a gift from the J and B Gates Foundation.

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