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

J Pediatr. 2019 Oct:213:222-226.e2. doi: 10.1016/j.jpeds.2019.05.049. Epub 2019 Jun 27.

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.

Publication types

  • Comparative Study
  • Observational Study
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Bronchopulmonary Dysplasia / complications
  • Drug Administration Schedule*
  • Ductus Arteriosus, Patent / drug therapy*
  • Female
  • Humans
  • Infant, Extremely Premature
  • Infant, Low Birth Weight
  • Infant, Newborn
  • Infant, Premature, Diseases / therapy
  • Male
  • Maternal Age
  • Multicenter Studies as Topic
  • Patient Selection*
  • Prospective Studies
  • Randomized Controlled Trials as Topic*
  • Research Design*
  • Risk
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT01958320