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Lack of Equipoise in the PDA-TOLERATE Trial: A Comparison of Eligible Infants Enrolled in the Trial and Those Treated Outside the Trial

2019; Elsevier BV; Volume: 213; Linguagem: Inglês

10.1016/j.jpeds.2019.05.049

1097-6833

Melissa Liebowitz, Anup Katheria, Jason Sauberan, Jaideep Singh, Kelly C. Nelson, Denise C. Hassinger, Susan W. Aucott, Joseph W. Kaempf, Amy Kimball, Erika Fernandez, William A. Carey, Jorge Perez, Arturo Serize, Andrea C. Wickremasinghe, Lawrence Dong, Matthew Derrick, Ilene Sue Wolf, Anne Marie Heuchan, Meera N. Sankar, Ali Bülbül, Ronald I. Clyman,

Neonatal Respiratory Health Research

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.