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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
- Liebowitz, Melissa;
- Katheria, Anup;
- Sauberan, Jason;
- Singh, Jaideep;
- Nelson, Kelly;
- Hassinger, Denise C;
- Aucott, Susan W;
- Kaempf, Joseph;
- Kimball, Amy;
- Fernandez, Erika;
- Carey, William A;
- Perez, Jorge;
- Serize, Arturo;
- Wickremasinghe, Andrea;
- Dong, Lawrence;
- Derrick, Matthew;
- Wolf, Ilene Sue;
- Heuchan, Anne Marie;
- Sankar, Meera;
- Bulbul, Ali;
- Clyman, Ronald I;
- Investigators, PDA-TOLERATE Trial
- et al.
Published Web Location
https://doi.org/10.1016/j.jpeds.2019.05.049Abstract
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.
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