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; Aucott, Susan; Kaempf, Joseph; Kimball, Amy; Fernandez, Erika; Carey, William; Perez, Jorge; Serize, Arturo; Wickremasinghe, Andrea; Dong, Lawrence; Derrick, Matthew; Wolf, Ilene; Heuchan, Anne; Sankar, Meera; BÜLBÜL, Ali; Clyman, Ronald

doi:10.1016/j.jpeds.2019.05.049

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

Liebowitz M., Katheria A., Sauberan J., Singh J., Nelson K., Hassinger D. C., ...Daha Fazla

Journal of Pediatrics, cilt.213, ss.222, 2019 (SCI-Expanded, Scopus)

Yayın Türü: Makale / Tam Makale
Cilt numarası: 213
Basım Tarihi: 2019
Doi Numarası: 10.1016/j.jpeds.2019.05.049
Dergi Adı: Journal of Pediatrics
Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
Sayfa Sayıları: ss.222
Anahtar Kelimeler: bronchopulmonary dysplasia, patent ductus arteriosus, premature birth
Sağlık Bilimleri Üniversitesi Adresli: Evet

Özet

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.