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

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

Research output: Contribution to journalArticle

3 Scopus citations

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.

Original languageEnglish (US)
JournalJournal of Pediatrics
DOIs
StateAccepted/In press - Jan 1 2019

    Fingerprint

Keywords

  • bronchopulmonary dysplasia
  • patent ductus arteriosus
  • premature birth

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Liebowitz, M., Katheria, A., Sauberan, J., Singh, J., Nelson, K., Hassinger, D. C., Aucott, S. W., Kaempf, J., Kimball, A., Fernandez, E., Carey, W. A., Perez, J., Serize, A., Wickremasinghe, A., Dong, L., Derrick, M., Wolf, I. S., Heuchan, A. M., Sankar, M., ... Clyman, R. I. (Accepted/In press). Lack of Equipoise in the PDA-TOLERATE Trial: A Comparison of Eligible Infants Enrolled in the Trial and Those Treated Outside the Trial. Journal of Pediatrics. https://doi.org/10.1016/j.jpeds.2019.05.049