@article{878787c145df49768c19535356afa0bd,
title = "Lack of Equipoise in the PDA-TOLERATE Trial: A Comparison of Eligible Infants Enrolled in the Trial and Those Treated Outside the Trial",
abstract = "The PDA: TO LEave it alone or Respond And Treat Early trial compared the effects of 2 strategies for treatment of patent ductus arteriosus (PDA) in infants <280/7 weeks of gestation; however 137 potentially eligible infants were not recruited and received treatment of their PDA outside the PDA-TOLERATE trial due to “lack-of-physician-equipoise” (LPE). Despite being less mature and needing more respiratory support, infants with LPE had lower rates of mortality than enrolled infants. Infants with LPE treated before day 6 had lower rates of late respiratory morbidity than infants with LPE treated ≥day 6. Trial registration: ClinicalTrials.gov: NCT01958320.",
keywords = "bronchopulmonary dysplasia, patent ductus arteriosus, premature birth",
author = "{PDA-TOLERATE (PDA: TO LEave it alone or Respond And Treat Early) Trial Investigators} and Melissa Liebowitz and Anup Katheria and Jason Sauberan and Jaideep Singh and Kelly Nelson and Hassinger, {Denise C.} and Aucott, {Susan W.} and Joseph Kaempf and Amy Kimball and Erika Fernandez and Carey, {William A.} and Jorge Perez and Arturo Serize and Andrea Wickremasinghe and Lawrence Dong and Matthew Derrick and Wolf, {Ilene Sue} and Heuchan, {Anne Marie} and Meera Sankar and Ali Bulbul and Clyman, {Ronald I.}",
note = "Funding Information: Supported by grants from the Gerber Foundation; US Public Health Service; National Heart, Lung, and Blood Institute (HL109199); National Center for Advancing Translational Sciences, National Institutes of Health (through UL1 TR001872, UL1 TR000004, and UL1TR001873); and a gift from the Jamie and Bobby Gates Foundation. The authors declare no conflicts of interest. Publisher Copyright: {\textcopyright} 2019 Elsevier Inc.",
year = "2019",
month = oct,
doi = "10.1016/j.jpeds.2019.05.049",
language = "English (US)",
volume = "213",
pages = "222--226.e2",
journal = "Journal of Pediatrics",
issn = "0022-3476",
publisher = "Mosby Inc.",
}