Literature DB >> 31255386

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

Melissa Liebowitz1, Anup Katheria2, Jason Sauberan2, Jaideep Singh3, Kelly Nelson3, Denise C Hassinger4, Susan W Aucott5, Joseph Kaempf6, Amy Kimball7, Erika Fernandez7, William A Carey8, Jorge Perez9, Arturo Serize9, Andrea Wickremasinghe10, Lawrence Dong10, Matthew Derrick11, Ilene Sue Wolf11, Anne Marie Heuchan12, Meera Sankar13, Ali Bulbul14, Ronald I Clyman15.   

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.
Copyright © 2019 Elsevier Inc. All rights reserved.

Entities:  

Keywords:  bronchopulmonary dysplasia; patent ductus arteriosus; premature birth

Mesh:

Year:  2019        PMID: 31255386      PMCID: PMC6765426          DOI: 10.1016/j.jpeds.2019.05.049

Source DB:  PubMed          Journal:  J Pediatr        ISSN: 0022-3476            Impact factor:   4.406


  4 in total

Review 1.  Patent Ductus Arteriosus of the Preterm Infant.

Authors:  Shannon E G Hamrick; Hannes Sallmon; Allison T Rose; Diego Porras; Elaine L Shelton; Jeff Reese; Georg Hansmann
Journal:  Pediatrics       Date:  2020-11       Impact factor: 7.124

Review 2.  Does crossover treatment of control subjects invalidate results of randomized trials of patent ductus arteriosus treatment?

Authors:  Meera N Sankar; William E Benitz
Journal:  J Perinatol       Date:  2020-10-06       Impact factor: 2.521

3.  Early treatment versus expectant management of hemodynamically significant patent ductus arteriosus for preterm infants.

Authors:  Souvik Mitra; Alexandra Scrivens; Adelaide M von Kursell; Tim Disher
Journal:  Cochrane Database Syst Rev       Date:  2020-12-10

4.  Intraventricular Hemorrhage: Risk Factors and Association With Patent Ductus Arteriosus Treatment in Extremely Preterm Neonates.

Authors:  Ijab Khanafer-Larocque; Amuchou Soraisham; Amelie Stritzke; Essa Al Awad; Sumesh Thomas; Prashanth Murthy; Majeeda Kamaluddeen; James N Scott; Khorshid Mohammad
Journal:  Front Pediatr       Date:  2019-10-22       Impact factor: 3.418

  4 in total

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