TY - JOUR
T1 - PDA-TOLERATE Trial
T2 - An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age
AU - 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)
AU - NCRC Nurses
AU - Umea University Hospital
AU - Kaiser Permanente Santa Clara Medical Center
AU - Clyman, Ronald I.
AU - Liebowitz, Melissa
AU - Kaempf, Joseph
AU - Erdeve, Omer
AU - Bulbul, Ali
AU - Håkansson, Stellan
AU - Lindqvist, Johanna
AU - Farooqi, Aijaz
AU - Katheria, Anup
AU - Sauberan, Jason
AU - Singh, Jaideep
AU - Nelson, Kelly
AU - Wickremasinghe, Andrea
AU - Dong, Lawrence
AU - Hassinger, Denise C.
AU - Aucott, Susan W.
AU - Hayashi, Madoka
AU - Heuchan, Anne Marie
AU - Carey, William A.
AU - Derrick, Matthew
AU - Fernandez, Erika
AU - Sankar, Meera
AU - Leone, Tina
AU - Perez, Jorge
AU - Serize, Arturo
AU - Fields, Scott
AU - Whitten, Lora
AU - Rogers, Stefanie
AU - Okulu, Emel
AU - Tunc, Gaffari
AU - Ucar, Tayfun
AU - Ünal, Ebru Türkoglu
AU - Steen, Jane
AU - Arnell, Kathy
AU - Holtschlag, Sarah
AU - Schreiber, Michael
AU - Peters, Caryn
AU - Gilmore, Maureen
AU - McKay, Lorna
AU - Carole, Dianne
AU - Shaw, Annette
AU - Harris, Malinda
AU - Amsbaugh, Amy
AU - Liedl, Lavonne M.
AU - Wolf, Sue
AU - Groner, Avi
AU - Kimball, Amy
AU - Kim, Jae
AU - Bridge, Renee
AU - Knodel, Ellen
N1 - Funding Information:
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.
Funding Information:
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.
Publisher Copyright:
© 2018 Elsevier Inc.
PY - 2019/2
Y1 - 2019/2
N2 - 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.
AB - 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.
KW - bronchopulmonary dysplasia
KW - necrotizing enterocolitis
KW - newborn
KW - premature birth
KW - retinopathy of prematurity
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U2 - 10.1016/j.jpeds.2018.09.012
DO - 10.1016/j.jpeds.2018.09.012
M3 - Article
C2 - 30340932
AN - SCOPUS:85055017989
VL - 205
SP - 41-48.e6
JO - Journal of Pediatrics
JF - Journal of Pediatrics
SN - 0022-3476
ER -