PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age

PDA-TOLERATE (PDA: TO LEave it alone or Respond And Treat Early) Trial Investigators A list of additional PDA-TOLERATE Investigators is available at www.jpeds.com (Appendix), NCRC Nurses, Umea University Hospital, Kaiser Permanente Santa Clara Medical Center

Research output: Contribution to journalArticle

27 Scopus citations

Abstract

Objective: To compare early routine pharmacologic treatment of moderate-to-large patent ductus arteriosus (PDA) at the end of week 1 with a conservative approach that requires prespecified respiratory and hemodynamic criteria before treatment can be given. Study design: A total of 202 neonates of <28 weeks of gestation age (mean, 25.8 ± 1.1 weeks) with moderate-to-large PDA shunts were enrolled between age 6 and 14 days (mean, 8.1 ± 2.2 days) into an exploratory randomized controlled trial. Results: At enrollment, 49% of the patients were intubated and 48% required nasal ventilation or continuous positive airway pressure. There were no differences between the groups in either our primary outcome of ligation or presence of a PDA at discharge (early routine treatment [ERT], 32%; conservative treatment [CT], 39%) or any of our prespecified secondary outcomes of necrotizing enterocolitis (ERT, 16%; CT, 19%), bronchopulmonary dysplasia (BPD) (ERT, 49%; CT, 53%), BPD/death (ERT, 58%; CT, 57%), death (ERT,19%; CT, 10%), and weekly need for respiratory support. Fewer infants in the ERT group met the rescue criteria (ERT, 31%; CT, 62%). In secondary exploratory analyses, infants receiving ERT had significantly less need for inotropic support (ERT, 13%; CT, 25%). However, among infants who were ≥26 weeks gestational age, those receiving ERT took significantly longer to achieve enteral feeding of 120 mL/kg/day (median: ERT, 14 days [range, 4.5-19 days]; CT, 6 days [range, 3-14 days]), and had significantly higher incidences of late-onset non-coagulase-negative Staphylococcus bacteremia (ERT, 24%; CT,6%) and death (ERT, 16%; CT, 2%). Conclusions: In preterm infants age <28 weeks with moderate-to-large PDAs who were receiving respiratory support after the first week, ERT did not reduce PDA ligations or the presence of a PDA at discharge and did not improve any of the prespecified secondary outcomes, but delayed full feeding and was associated with higher rates of late-onset sepsis and death in infants born at ≥26 weeks of gestation. Trial registration: ClinicalTrials.gov: NCT01958320.

Original languageEnglish (US)
Pages (from-to)41-48.e6
JournalJournal of Pediatrics
Volume205
DOIs
StatePublished - Feb 2019

Keywords

  • bronchopulmonary dysplasia
  • necrotizing enterocolitis
  • newborn
  • premature birth
  • retinopathy of prematurity

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

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    PDA-TOLERATE (PDA: TO LEave it alone or Respond And Treat Early) Trial Investigators A list of additional PDA-TOLERATE Investigators is available at www.jpeds.com (Appendix), NCRC Nurses, Umea University Hospital, & Kaiser Permanente Santa Clara Medical Center (2019). PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age. Journal of Pediatrics, 205, 41-48.e6. https://doi.org/10.1016/j.jpeds.2018.09.012