PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age - 24/01/19
, Melissa Liebowitz, MD 1, Joseph Kaempf, MD 3, Omer Erdeve, MD 4, Ali Bulbul, MD 5, Stellan Håkansson, MD 6, Johanna Lindqvist, MD 6, Aijaz Farooqi, MD 6, Anup Katheria, MD 7, Jason Sauberan, PharmD 7, Jaideep Singh, MD 8, Kelly Nelson, MD 8, Andrea Wickremasinghe, MD 9, Lawrence Dong, MD 9, Denise C. Hassinger, MD 10, Susan W. Aucott, MD 11, Madoka Hayashi, MD 11, Anne Marie Heuchan, MD 12, William A. Carey, MD 13, Matthew Derrick, MD 14, Erika Fernandez, MD 15, Meera Sankar, MD 16, Tina Leone, MD 17, Jorge Perez, MD 18, Arturo Serize, PA 18and the
PDA-TOLERATE (PDA: TO LEave it alone or Respond And Treat Early) Trial Investigators*
NCRC Nurses19
Lora Whitten, RN 20, Stefanie Rogers, MD 20, Emel Okulu, MD 21, Gaffari Tunc, MD 21, Tayfun Ucar, MD 21, Ebru Türkoglu Ünal, MD 22, Jane Steen, RN 23, Kathy Arnell, RN 23, Sarah Holtschlag, RN 24, Michael Schreiber, MD 24, Caryn Peters, RN 25, Maureen Gilmore, MD 26, Lorna McKay, RN 27, Dianne Carole, RN 27, Annette Shaw, RN 27, Malinda Harris, MD 28, Amy Amsbaugh, RRT 28, Lavonne M. Liedl, RRT 28, Sue Wolf, RN 29, Avi Groner, MD 29, Amy Kimball, MD 30, Jae Kim, MD 30, Renee Bridge, RN 30, Ellen Knodel, RN 30, Chrissy Weng, RN 31, Magaly Diaz Barbosa, MD 32, Richard Polin, MD 33, Marilyn Weindler, RN 33, Shahab Noori, MD 34, Jeffrey Reese, MD 35, Yao Sun, MD 36Umea University Hospital
Kaiser Permanente Santa Clara Medical Center
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.
Le texte complet de cet article est disponible en PDF.Keywords : newborn, premature birth, bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis
Abbreviations : BPD, CPAP, CT, ERT, FiO2, NEC, PDA, RCT
Plan
| Supported by grants from the Gerber Foundation, US Public Health Service, National Heart, Lung and Blood Institute (HL109199), National Center for Advancing Translational Sciences, and National Institutes of Health (UL1 TR001872, UL1 TR000004, and UL1TR001873), and a gift from the Jamie and Bobby Gates Foundation. The authors declare no conflicts of interest. |
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| Portions of this study were presented at the Pediatric Academic Societies annual meeting, Toronto, ON, Canada, May 5-8, 2018. |
Vol 205
P. 41 - février 2019 Retour au numéro
Article précédent
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