دورية أكاديمية
PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age.
| العنوان: | PDA-TOLERATE Trial: An Exploratory Randomized Controlled Trial of Treatment of Moderate-to-Large Patent Ductus Arteriosus at 1 Week of Age. |
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| المؤلفون: | Clyman RI; Department of Pediatrics, University of California San Francisco, San Francisco, CA; Cardiovascular Research Institute, University of California San Francisco, San Francisco, CA. Electronic address: clymanr@peds.ucsf.edu., Liebowitz M; Department of Pediatrics, University of California San Francisco, San Francisco, CA., Kaempf J; Department of Pediatrics, Providence St. Vincent Medical Center, Portland, OR., Erdeve O; Department of Pediatrics, Ankara University School of Medicine Children's Hospital, Ankara, Turkey., Bulbul A; Department of Pediatrics, Sisli Hamidiye Etfal Training and Research Hospital, İstanbul, Turkey., Håkansson S; Department of Pediatrics, Umea University Hospital, Umea, Sweden., Lindqvist J; Department of Pediatrics, Umea University Hospital, Umea, Sweden., Farooqi A; Department of Pediatrics, Umea University Hospital, Umea, Sweden., Katheria A; Department of Pediatrics, Sharp Mary Birch Hospital, San Diego, CA., Sauberan J; Department of Pediatrics, Sharp Mary Birch Hospital, San Diego, CA., Singh J; Department of Pediatrics, University of Chicago, Chicago, IL., Nelson K; Department of Pediatrics, University of Chicago, Chicago, IL., Wickremasinghe A; Department of Pediatrics, Kaiser Permanente Santa Clara Medical Center, Santa Clara, CA., Dong L; Department of Pediatrics, Kaiser Permanente Santa Clara Medical Center, Santa Clara, CA., Hassinger DC; Department of Pediatrics, Morristown Medical Center, Morristown, NJ., Aucott SW; Department of Pediatrics, Johns Hopkins University, Baltimore, MD., Hayashi M; Department of Pediatrics, Johns Hopkins University, Baltimore, MD., Heuchan AM; Department of Pediatrics, University of Glasgow, Royal Hospital for Sick Children, Glasgow, Scotland, United Kingdom., Carey WA; Department of Pediatrics, Mayo Clinic, Rochester, MN., Derrick M; Department of Pediatrics, Northshore University Health System, Evanston, IL., Fernandez E; Department of Pediatrics, University of California San Diego and Rady Children's Hospital, San Diego, CA., Sankar M; Department of Pediatrics, Good Samaritan Hospital, San Jose, CA., Leone T; Department of Pediatrics, Columbia University Medical Center, New York, NY., Perez J; Department of Pediatrics, South Miami Hospital/Baptist Health South Florida, Miami, FL., Serize A; Department of Pediatrics, South Miami Hospital/Baptist Health South Florida, Miami, FL. |
| مؤلفون مشاركون: | PDA-TOLERATE (PDA: TO LEave it alone or Respond And Treat Early) Trial Investigators |
| المصدر: | The Journal of pediatrics [J Pediatr] 2019 Feb; Vol. 205, pp. 41-48.e6. Date of Electronic Publication: 2018 Oct 16. |
| نوع المنشور: | Journal Article; Pragmatic Clinical Trial; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Mosby Country of Publication: United States NLM ID: 0375410 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6833 (Electronic) Linking ISSN: 00223476 NLM ISO Abbreviation: J Pediatr Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: St. Louis, MO : Mosby |
| مواضيع طبية MeSH: | Conservative Treatment*, Acetaminophen/*therapeutic use , Cyclooxygenase Inhibitors/*therapeutic use , Ductus Arteriosus, Patent/*therapy , Ibuprofen/*therapeutic use , Indomethacin/*therapeutic use, Continuous Positive Airway Pressure ; Ductus Arteriosus, Patent/classification ; Female ; Gestational Age ; Humans ; Infant, Extremely Premature ; Infant, Newborn ; Male ; Prospective Studies ; Single-Blind Method ; Treatment Outcome |
| مستخلص: | 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. (Copyright © 2018 Elsevier Inc. All rights reserved.) |
| التعليقات: | Comment in: Acta Paediatr. 2019 Jul;108(7):1363. (PMID: 31039276) |
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| معلومات مُعتمدة: | R01 HL128386 United States HL NHLBI NIH HHS; UL1 TR001872 United States TR NCATS NIH HHS; R01 HL109199 United States HL NHLBI NIH HHS; UL1 TR001873 United States TR NCATS NIH HHS; UL1 TR000004 United States TR NCATS NIH HHS |
| فهرسة مساهمة: | Investigator: S Fields, University of California San Francisco, San Francisco, CA.; L Whitten, Providence St. Vincent Medical Center, Portland, OR.; S Rogers, Providence St. Vincent Medical Center, Portland, OR.; E Okulu, Ankara University School of Medicine Children's Hospital, Ankara, Turkey.; G Tunc, Ankara University School of Medicine Children's Hospital, Ankara, Turkey.; T Ucar, Ankara University School of Medicine Children's Hospital, Ankara, Turkey.; ET Ünal, Sisli Hamidiye Etfal Training and Research Hospital, İstanbul, Turkey.; J Steen, Sharp Mary Birch Hospital, San Diego, CA.; K Arnell, Sharp Mary Birch Hospital, San Diego, CA.; S Holtschlag, University of Chicago, Chicago, IL.; M Schreiber, University of Chicago, Chicago, IL.; C Peters, Morristown Medical Center, Morristown, NJ.; M Gilmore, Johns Hopkins Hospital, Baltimore, MD.; L McKay, University of Glasgow, Royal Hospital for Sick Children, Glasgow, Scotland, United Kingdom.; D Carole, University of Glasgow, Royal Hospital for Sick Children, Glasgow, Scotland, United Kingdom.; A Shaw, University of Glasgow, Royal Hospital for Sick Children, Glasgow, Scotland, United Kingdom.; M Harris, Mayo Clinic, Rochester, MN.; A Amsbaugh, Mayo Clinic, Rochester, MN.; LM Liedl, Mayo Clinic, Rochester, MN.; S Wolf, Northshore University Health System, Evanston, IL.; A Groner, Northshore University Health System, Evanston, IL.; A Kimball, University of California San Diego and Rady Children's Hospital, San Diego, CA.; J Kim, University of California San Diego and Rady Children's Hospital, San Diego, CA.; R Bridge, University of California San Diego and Rady Children's Hospital, San Diego, CA.; E Knodel, University of California San Diego and Rady Children's Hospital, San Diego, CA.; C Weng, Good Samaritan Hospital, San Jose, CA.; MD Barbosa, South Miami Hospital/Baptist Health South Florida, Miami, FL.; R Polin, Columbia University Medical Center, New York, NY.; M Weindler, Columbia University Medical Center, New York, NY.; S Noori, University of Southern California, Los Angeles, CA.; J Reese, Vanderbilt University, Nashville, TN.; Y Sun, University of California San Francisco, San Francisco, CA. Keywords: bronchopulmonary dysplasia; necrotizing enterocolitis; newborn; premature birth; retinopathy of prematurity |
| سلسلة جزيئية: | ClinicalTrials.gov NCT01958320 |
| المشرفين على المادة: | 0 (Cyclooxygenase Inhibitors) 362O9ITL9D (Acetaminophen) WK2XYI10QM (Ibuprofen) XXE1CET956 (Indomethacin) |
| تواريخ الأحداث: | Date Created: 20181021 Date Completed: 20191024 Latest Revision: 20200309 |
| رمز التحديث: | 20231215 |
| مُعرف محوري في PubMed: | PMC6502709 |
| DOI: | 10.1016/j.jpeds.2018.09.012 |
| PMID: | 30340932 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1097-6833 |
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| DOI: | 10.1016/j.jpeds.2018.09.012 |