Early Surgical Ligation Versus a Conservative Approach for Management of Patent Ductus Arteriosus That Fails to Close after Indomethacin Treatment
Objective
To examine whether a more conservative approach to treating patent ductus arteriosus (PDA) is associated with an increase or decrease in morbidity compared with an approach involving early PDA ligation.
Study design
In January 2005, we changed our approach to infants born at age ≤27 weeks gestation who failed indomethacin treatment. We changed from an early surgical approach, in which feedings were stopped and all PDAs were ligated (period 1: January 1999 to December 2004; n = 216) to a more conservative approach in which feedings continued and PDAs were ligated only if cardiopulmonary compromise developed (period 2: January 2005 to August 2009; n = 180). All infants in both periods received prophylactic indomethacin therapy.
Results
The 2 periods had similar rates of perinatal/neonatal risk factors and indomethacin failure (24%), as well as ventilator management and feeding advance protocols. The conservative approach (period 2) was associated with decreased rates of duct ligation (72% vs 100%; P <.05). Even though infants subjected to this approach were exposed to larger PDA shunts for longer durations, the rates of bronchopulmonry dysplasia, sepsis, retinopathy of prematurity, neurologic injury, and death were similar to those in period 1. The overall rate of necrotizing enterocolitis was significantly lower in period 2 compared with period 1.
Conclusions
These findings support the need for new controlled, randomized trials to reexamine the benefits and risks of different approaches to PDA treatment.
BPD, Bronchopulmonary dysplasia, CI, Confidence interval, ICH, Intracranial hemorrhage, LA/Ao, Left atrium/aortic root, NEC, Necrotizing enterocolitis, OR, Odds ratio, PDA, Patent ductus arteriosus, PVL, Periventricular leukomalacia, RCT, Randomized controlled trial, ROP, Retinopathy of prematurity, RSS, Respiratory Severity Score
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Supported in part by grants from the US Public Health Service (Grants NHLBI HL46691 and NIH/NCRR UCSF-CTSI UL1 RR024131) and a gift from the Jamie and Bobby Gates Foundation. R.C. received a research grant from Ovation Pharmaceuticals, Inc. The other authors declare no conflicts of interest.
PII: S0022-3476(10)00206-4
doi:10.1016/j.jpeds.2010.02.062
© 2010 Mosby, Inc. All rights reserved.
