OBJECTIVE-The purpose of this work was to evaluate therapy for patent ductus arteri-osus as a risk factor for death or neurodevelopmental impairment at 18 to 22 months, bronchopulmonary dysplasia, or necrotizing enterocolitis in extremely low birth weight infants.
METHODS-We studied infants in the National Institute of Child Health and Human DevelopmentNeonatal Research Network Generic Data Base born between 2000 and 2004 at 23 to 28 weeks' gestation and at <1000-g birth weight with patent ductus arteriosus. Patent ductus arteriosus therapy was evaluated as a risk factor for outcomes in bivariable and multivariable analyses.RESULTS-Treatment for subjects with patent ductus arteriosus (n = 2838) included 403 receiving supportive treatment only, 1525 treated with indomethacin only, 775 with indomethacin followed by secondary surgical closure, and 135 treated with primary surgery. Patients who received supportive therapy for patent ductus arteriosus did not differ from subjects treated with indomethacin only for any of the outcomes of interest. Compared with indomethacin treatment only, patients undergoing primary or secondary surgery were smaller and more premature. When compared with indomethacin alone, primary surgery was associated with increased adjusted odds for neurodevelopmental impairment and bronchopulmonary dysplasia in multivariable logistic regression. Secondary surgical closure was associated with increased odds for neurodevelopmental impairment and increased adjusted odds for bronchopulmonary dysplasia but decreased adjusted odds for death. Risk of necrotizing enterocolitis did not differ among treatments. Indomethacin prophylaxis did not significantly modify these results.CONCLUSIONS-Our results suggest that infants treated with primary or secondary surgery for patent ductus arteriosus may be at increased risk for poor short-and long-term outcomes compared with those treated with indomethacin. Prophylaxis with indomethacin in the first 24 hours of life did not modify the subsequent outcomes of patent ductus arteriosus therapy.
What This Study AddsOur analysis of 2838 infants with PDA in the NRN GDB showed that those treated with indomethacin, when compared with those with supportive care, had similar outcomes, and those with surgical ligation had more complications.Clinically significant patent ductus arteriosus (PDA) occurs in ~49% of extremely low birth weight (ELBW) infants with weights of 501 to 750 g and 38% of infants with weights of 751 to 1000 g. 1,2 Infants with PDA may be at increased risk for necrotizing enterocolitis (NEC), bronchopulmonary dysplasia (BPD), or intraventricular hemorrhage (IVH). [3][4][5][6][7] The most premature infants are more likely to have a significant PDA, least likely to respond to indomethacin, and more likely to reopen the ductus. [8][9][10][11][12][13][14][15] Optimal therapy for PDA remains controversial. The only direct comparison of primary medical versus surgical treatment did not include infants <29 weeks' gestation and was completed before the wi...