Lack of Equipoise in the PDA-TOLERATE Trial: A Comparison of Eligible Infants Enrolled in the Trial and Those Treated Outside the Trial.
retrospective_cohort · Level III
Where this comes from
- Record sourced from PubMed, PMID 31255386.
- Also identified by DOI 10.1016/j.jpeds.2019.05.049 and PMC identifier 6765426.
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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 <28<sup>0/7</sup> 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.
Medical subject headings
- Drug Administration Schedule
- Ductus Arteriosus, Patent
- Patient Selection
- Randomized Controlled Trials as Topic
- Research Design