Initial Laparotomy Versus Peritoneal Drainage in Extremely Low Birthweight Infants With Surgical Necrotizing Enterocolitis or Isolated Intestinal Perforation (original) (raw)

Abstract

; investigation; writing review and editing Henry Rice, MD-conceptualization; investigation; writing review and editing Arlet G. Kurkchubasche, MD-conceptualization; investigation; writing review and editing Karl Sylvester, MD-conceptualization; investigation; writing review and editing James C. Y. Dunn, MD PhD-conceptualization; investigation; writing review and editing Troy A. Markel, MD-investigation; writing review and editing Diana L. Diesen, MD-investigation; writing review and editing Amina M. Bhatia, MD MS-conceptualization; investigation; writing review and editing Alan Flake, MD-conceptualization; investigation; writing review and editing Walter J. Chwals, MD-conceptualization; investigation; writing review and editing Rebeccah Brown, MD-conceptualization; investigation; writing review and editing Kathryn D. Bass, MD MBA-conceptualization; investigation; writing review and editing Shawn D. St. Peter, MD-conceptualization; investigation; writing review and editing Christina M. Shanti, MD-conceptualization; investigation; writing review and editing Walter Pegoli, Jr, MD-conceptualization; investigation; writing review and editing David Skarda, MD-conceptualization; investigation; writing review and editing Joel Shilyansky, MD-conceptualization; investigation; writing review and editing David G. Lemon, MD-conceptualization; investigation; writing review and editing Ricardo A. Mosquera, MD MS-investigation; data acquisition; writing review and editing Myriam Peralta-Carcelen, MD MPH-investigation; data acquisition; writing review and editing Ricki F.

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References (70)

  1. Case Western Reserve University, Rainbow Babies & Children's Hospital (UG1 HD21364) -Anna Maria Hibbs, MD MSCE; Nancy S. Newman, RN; Edward M. Barksdale, Jr., MD.
  2. Children's Mercy Hospital (UG1 HD68284) -Eugenia K. Pallotto, MD MSCE; Cheri Gauldin, RN BS CCRC;
  3. George M. Holcomb III, MD MBA; Dan Ostlie, MD; Anne Holmes, RN MSN MBA-HCM CCRC; Kathy Johnson RN, CCRC; Allison Scott, RNC-NIC BSN CCRC; Prabhu S. Parimi, MD; Lisa Gaetano, RN MSN.
  4. Cincinnati Children's Hospital Medical Center (UG1 HD27853, UL1 TR77) -Kurt Schibler, MD; Michael A. Helmrath, MD MS; Stephanie L. Merhar, MD MS; Tanya E. Cahill, MD; Teresa L. Gratton, PA; Cathy Grisby, BSN CCRC;
  5. Kristin Kirker, CRC; Sandra Wuertz, RN BSN CLC.
  6. Duke University School of Medicine, University Hospital, University of North Carolina, Duke Regional Hospital, and WakeMed Health and Hospitals (UG1 HD40492, UL1 TR1117) -Ronald N. Goldberg, MD; William Adamson, MD;
  7. Obinna O. Adibe, MD; Joanne Finkle, RN JD; William F. Malcolm, MD; Patricia L. Ashley, MD PhD;
  8. Kimberley A. Fisher, PhD FNP-BC IBCLC; Sandra Grimes, RN BSN; Kathryn E. Gustafson, PhD; Melody B. Lohmeyer, RN MSN; Carl L. Bose, MD; Janice Bernhardt, MS RN; Gennie Bose, RN; Janice Wereszczak, CPNP-AC/PC; Stephen D. Kicklighter, MD; Ginger Rhodes-Ryan, ARNP MSN, NNP-BC.
  9. Emory University, Children's Healthcare of Atlanta, Grady Memorial Hospital, and Emory University Hospital Midtown (UG1 HD27851, UL1 TR454) -Ira Adams-Chapman, MD (deceased);
  10. David P. Carlton, MD; Ellen C. Hale, RN BS CCRC; Yvonne Loggins, RN; Richard Ricketts, MD; Diane I. Bottcher, RN MSN; Sheena L. Carter, PhD; Salathiel Kendrick-Allwood, MD; Maureen Mulligan LaRossa, RN; Colleen Mackie, RRT; Gloria Smikle, PNP MSN; Lynn C. Comerford, NNP.
  11. Eunice Kennedy Shriver National Institute of Child Health and Human Development -Stephanie Wilson Archer, MA. Indiana University, University Hospital, Methodist Hospital, Riley Hospital for Children, and Wishard Health Services (UG1 HD27856, UL1 TR6) -Brenda B. Poindexter, MD MS; Scott A. Engum, MD; Charles M. Leys, MD MSCI; Lu-Ann Papile, MD; Heidi Harmon, MD MS; Dianne E. Herron, RN CCRC; Carolyn Lytle, MD MPH;
  12. Lucy C. Miller, RN BSN CCRC; Heike M. Minnich, PsyD HSPP; Lucy Smiley, CCRC; Leslie Dawn Wilson, BSN CCRC. McGovern Medical School at The University of Texas Health Science Center at Houston, Children's Memorial Hermann Hospital, and Memorial Hermann Southwest Hospital (UG1 HD21373) -Georgia McDavid, RN; Emily K. Stephens, RN BSN-NIC;
  13. KuoJen Tsao, MD; Elizabeth Allen, MS; Julie Arldt-McAlister, RN BSN; Katrina Burson, RN BSN; Allison G. Dempsey, PhD; Andrea F. Duncan, MD MSc; Elizabeth Eason, MD; Patricia W. Evans, MD; Carmen Garcia, RN CCRP; Donna Hall, RN; Beverly Harris, RN BSN; Margarita Jiminez, MD MPH;
  14. Janice John, CPNP; Patrick M. Jones, MD MA; Amir Khan, MD; M. Layne Lillie, RN BSN; Karen Martin, RN;
  15. Carrie M. Mason, MA LPA; Kimberly Rennie, PhD; Sara C. Martin, RN BSN; Shannon McKee, EdS; Michelle Poe, PhD;
  16. Shawna Rodgers, RN BSN; Saba Khan Siddiki, MD; Daniel Sperry, RN; Patti L. Pierce Tate, RCP; Sharon L. Wright, MT (ASCP).
  17. Nationwide Children's Hospital, Abigail Wexner Research Institute at Nationwide Children's Hospital, Center for Perinatal Research, The Ohio State University College of Medicine, and The Ohio State University Wexner Medical Center (UG1 HD68278) -Sudarshan R. Jadcherla, MD; Patricia Luzader, RN; Christine A. Fortney, RN, PhD; R. Lawrence Moss, MD; Keith O. Yeates, PhD; Julie Gutentag, RN, BSN; Christopher J. Timan, MD; Kristi L. Small, BS;
  18. Rox Ann Sullivan, RN, BSN; Jacqueline McCool; Melanie Stein, RRT, BBA; Erin Ferns; Lorraine Kelly Quan, MD;
  19. Rajan Thakkar, MD; Cole Hague, BA, MS; Stephanie Burkhardt, BS, MPH; Jessica Purnell, BS, CCRC; Mary Ann Nelin, MD; Helen Carey, PT, DHSc, PCS; Lindsay Pietruszewski, PT, DPT RTI International (UG1 HD36790) -Dennis Wallace, PhD; Marie G. Gantz, PhD; Carla M. Bann, PhD; Jeanette O'Donnell Auman, BS; Margaret Crawford, BS; Jenna Gabrio, MPH; Jamie E. Newman, PhD MPH; Carolyn M. Petrie Huitema, MS; Kristin M. Zaterka-Baxter, RN BSN.
  20. Stanford University and Lucile Packard Children's Hospital (UG1 HD27880, UL1 TR93) -M. Bethany Ball, BS CCRC;
  21. Gary E. Hartman, MD; Barbara Bentley, PhD; Elizabeth Bruno, PhD; Maria Elena DeAnda, PhD; Anne M. DeBattista, RN PNP; Lynne C. Huffman, MD; Jean G. Kohn, MD MPH; Casey Krueger, PhD; Melinda S. Proud, RCP;
  22. Nicholas H. St. John, PhD; Hali Weiss, MD.
  23. Tufts Medical Center (U10 HD53119) -John M. Fiascone, MD; Brenda L. MacKinnon, RNC; Anne Kurfiss, MPH; Ellen Nylen, RN BSN; Paige T. Church, MD. University of Alabama at Birmingham Health System and Children's Hospital of Alabama (UG1 HD34216) - Namasivayam Ambalavanan, MD; Mike K. Chen, MD MBA; Carroll M. Harmon, MD PhD; Monica V. Collins, RN BSN MaEd;
  24. Shirley S. Cosby, RN BSN; Kirstin J. Bailey, PhD; Fred J. Biasini, PhD; Stephanie A. Chopko, PhD;
  25. Fred J. Biasini, PhD; Kristen C. Johnston, MSN CRNP; Mary Beth Moses, PT MS PCS; Cryshelle S. Patterson, PhD;
  26. Vivien A. Phillips, RN BSN; Julie Preskitt, MSOT MPH; Richard V. Rector, PhD; Sally Whitley, MA OTR-L FAOTA. University of California -Los Angeles, Mattel Children's Hospital, Santa Monica Hospital, Los Robles Hospital and Medical Center, and Olive View Medical Center (UG1 HD68270) -Uday Devaskar, MD; Meena Garg, MD;
  27. Stephen B. Shew, MD; Teresa Chanlaw, MPH. University of Iowa and Mercy Medical Center (UG1 HD53109, UL1 TR442) -John A. Widness, MD; Jane E. Brumbaugh, MD; Heidi M. Harmon, MD; Dan L. Ellsbury, MD; Karen J. Johnson, RN BSN; Jacky R. Walker, RN;
  28. Claire A. Goeke, RN; Mendi L. Schmelzel, MSN RN; Diane L. Eastman, RN CPNP MA; Donia B. Bass, MS ARNP NNP-BC; Tracy L. Tud, RN; Graeme J. Pitcher, MBBCh FCS(SA) FACS; Julia S. Shelton, MD MPH. University of New Mexico Health Sciences Center (UG1 HD53089, UL1 TR41) -Conra Backstrom Lacy, RN;
  29. Sandra Brown, BSN; Cynthia Reyes, MD; Carol Hartenberger, BSN MPH; Jean R. Lowe, PhD; Sandra Sundquist Beauman, MSN RNC-NIC; Mary Ruffner Hanson, RN BSN. University of Pennsylvania, Hospital of the University of Pennsylvania, Pennsylvania Hospital, and Children's Hospital of Philadelphia (UG1 HD68244) -Eric C. Eichenwald, MD; Haresh Kirpalani, MB MSc; Aasma S. Chaudhary, BS RRT; Soraya Abbasi, MD; Toni Mancini, RN BSN CCRC; Dara M. Cucinotta, RN; Judy C. Bernbaum, MD; Marsha Gerdes, PhD; Hallam Hurt, MD; Jonathan Snyder, RN BSN. University of Rochester Medical Center, Golisano Children's Hospital, and the University at Buffalo Women's and Children's Hospital of Buffalo (UG1 HD68263, UL1 TR42) -Dale L. Phelps, MD; Mary Rowan, RN; Christopher A. Gitzelmann, MD; Ronnie Guillet, MD PhD; Gary J. Myers, MD; Anne Marie Reynolds, MD MPH; Ann Marie Scorsone, MS CCRC; Kyle Binion, BS; Constance Orme, BA; Holly I.M. Wadkins, MA; Michael G. Sacilowski, MAT CCRC; Rosemary L. Jensen; Joan Merzbach, LMSW; William A. Zorn, PhD; Osman Farooq, MD; Deanna Maffett, RN; Ashley Williams, MSEd; Julianne Hunn, MSHCM; Stephanie Guilford, BS; Karen Wynn, RN;
  30. Michelle E. Hartley-McAndrew, MD; Caitlin Fallone, MA; Premini Sabaratnam, MPH; Emily Li, BA; Jennifer Donato, BS; Kimberly G. McKee, BS; Rachel Jones; Timothy P. Stevens, MD MPH; Derek Wakeman, MD; Kelly R. Coleman, PsyD; Jayasree Nair, MD. University of Texas Southwestern Medical Center, Parkland Health & Hospital System, and Children's Medical Center Dallas (UG1 HD40689) -Luc P. Brion, MD; Pablo J. Sánchez, MD; Diana M. Vasil, MSN BSN RNC-NIC;
  31. Sally S. Adams, MS RN CPNP; Lijun Chen, RN PhD; Maria M. De Leon, RN BSN; Francis Eubanks, RN BSN; Alicia Guzman; Elizabeth T. Heyne, MS MA PA-C PsyD; Lizette E. Lee, RN; Linda A. Madden, BSN RN CPNP;
  32. Nancy A. Miller, RN; Janet S. Morgan, RN; Lara Pavageau, MD; Pollieanna Sepulveda, RN BSN; Catherine Twell Boatman, MS CIMI; Joseph T. Murphy, MD; Li Ern Chen, MD MSCS; Anne C. Fischer, MD PhD; Julie R. Fuchs, MD. University of Utah University Hospital, Intermountain Medical Center, McKay-Dee Hospital, Utah Valley Hospital, and Primary Children's Medical Center (UG1 HD87226, U10 HD53124, UL1 RR25764) -Mariana Baserga, MD MSCI;
  33. Roger G. Faix, MD; Stephen D. Minton, MD; Carrie A. Rau, RN BSN CCRC; Karen A. Osborne, RN BSN CCRC;
  34. Cynthia Spencer, RNC; Kimberlee Weaver-Lewis, RN MS; Shawna Baker, RN; Jill Burnett, RNC; Michael Steffen, PhD; Kathryn D. Woodbury, RN BSN; Susan T. Schaefer, RRT RN BSN; Jennifer O. Elmont, RN BSN; D. Susan Christensen, RNC BSN; Earl Maxson, BSN.
  35. Wayne State University, Hutzel Women's Hospital, and Children's Hospital of Michigan (UG1 HD21385) -Beena G. Sood, MD MS; Steven Bruch, MD; Athina Pappas, MD; Sanjay Chawla, MD; Monika Bajaj, MD; Rebecca Bara, RN BSN; Kirsten Childs, RN BSN; Bogdan Panaitescu, MD PhD; Mary E. Johnson, RN BSN; Laura A. Goldston, MA; Stephanie A. Wiggins, MS; Mary K. Christensen, BA RRT; Martha D. Carlson, MD PhD; John Barks, MD.
  36. Yale University, Yale-New Haven Children's Hospital, and Bridgeport Hospital (U10 HD27871, UL1 TR142) - Richard A. Ehrenkranz, MD (deceased);
  37. Harris Jacobs, MD; Patricia Cervone, RN; Monica Konstantino, RN BSN; JoAnn Poulsen, RN; Janet Taft, RN BSN; Joanne Williams, RN BSN.
  38. Data and Safety Monitoring Committee -Christine A. Gleason, MD, chair, University of Washington; Marilee C. Allen, MD, Johns Hopkins University School of Medicine; Robert J. Boyle, MD, University of Virginia Health System; Traci Clemons, PhD, The EMMES Corporation; Mary E. D'Alton, MD, Columbia Ob/Gyn Midtown;
  39. Abhik Das (ex officio), PhD, RTI International; Martin Keszler MD, Georgetown University Hospital; Menachem Miodovnik, MD, Washington Hospital Center; T. Michael O'Shea, MD MPH, Wake Forest University School of Medicine;
  40. Michael G. Ross, M.D., M.P.H., Harbor-UCLA Medical Center; Robin Steinhorn, MD, The George Washington University; Steven J. Weiner, MS, The George Washington University; Marian Willinger (ex officio), MD, Eunice Kennedy Shriver National Institute of Child Health and Human Development. References
  41. Neu J, Walker WA. Necrotizing Enterocolitis. N Engl J Med2011; 364: 255-264. [PubMed: 21247316]
  42. Blakely ML, Tyson JE, Lally KP, et al.Laparotomy versus peritoneal drainage for necrotizing enterocolitis or isolated intestinal perforation in extremely low birth weight infants: outcomes through 18 months adjusted age. Pediatrics2006; 117(4): e680-687. [PubMed: 16549503]
  43. Hintz SR, Kendrick DE, Stoll BJ, et al.Neurodevelopmental and growth outcomes of extremely low birth weight infants after necrotizing enterocolitis. Pediatrics2005; 115(3): 696-703. [PubMed: 15741374]
  44. Wadhawan R, Oh W, Hintz SR, et al., Neurodevelopmental outcomes of extremely low birth weight infants with spontaneous intestinal perforation or surgical necrotizing enterocolitis. J Perinatol2014; 34(1): 64-70. [PubMed: 24135709]
  45. Pumberger W, Mayr M, Kohlhauser C, et al.Spontaneous localized intestinal perforation in very low birth weight infants: a distinct clinical entity different from necrotizing enterocolitis. J Am Coll Surg2002; 195: 796-803. [PubMed: 12495312]
  46. Cass DL, Brandt ML, Patel DL, et al.Peritoneal drainage as definitive treatment for neonates with isolated intestinal perforation. J Pediatr Surg2000; 35(11): 1531-1536. [PubMed: 11083416]
  47. Jakaitis BM, Bhatia AM. Definitive peritoneal drainage in the extremely low birth weight infant with spontaneous intestinal perforation: predictors and hospital outcomes. J Perinatol2015; 35(8): 607-611. [PubMed: 25856761]
  48. Ein SH, Marshall DG, Girvan D. Peritoneal drainage under local anesthesia for perforations from necrotizing enterocolitis. J Pediatr Surg1977; 12(6): 963-967. [PubMed: 592076]
  49. Moss RL, Dimmitt RA, Barnhart DC, et al.Laparotomy versus peritoneal drainage for necrotizing enterocolitis and perforation. N Engl J Med2006; 354: 2225-2234. [PubMed: 16723614]
  50. Rees CM, Eaton S, Kiely EM, et al.Peritoneal drainage or laparotomy for neonatal bowel perforation? A randomized controlled trial. Ann Surg2008; 248: 44-51. [PubMed: 18580206]
  51. Rao SC, Basani L, Simmer K, et al.Peritoneal drainage versus laparotomy as initial surgical treatment for perforated necrotizing enterocolitis or spontaneous intestinal perforation in preterm low birth weight infants. Cochrane Database Syst Rev2011615; (6): CD006182. [PubMed: 21678354]
  52. Flake AW. Necrotizing enterocolitis in preterm infants -is laparotomy necessary?N Engl J Med2006; 354(21): 2275-2276. [PubMed: 16723619]
  53. McCulloch P, Altman DG, Campbell WB, et al.No surgical innovation without evaluation: the IDEAL recommendations. Lancet2009; 374: 1105-1112. [PubMed: 19782876]
  54. Newman JE, Bann CM, Vohr BR, et al.Improving the Neonatal Research Network annual certification for neurologic examination of the 18-22 month child. J Pediatr2012;161(6):1041- 1046. [PubMed: 22748517]
  55. Legakos SW. Clinical trials and rare diseases. N Engl J Med2003;348:2455-2456. [PubMed: 12802033]
  56. Wijeysundera DN, Austin PC, Hux JE, et al.Bayesian statistical inference enhances the interpretation of contemporary randomized controlled trials. J Clin Epidemiol2009; 62:13-21. [PubMed: 18947971]
  57. Spiegelhalter DJ, Abrams KR, Myles JP. Bayesian approaches to clinical trials and health care evaluation. John Wiley & Sons Ltd., Chichester, West Sussex, England and Hoboken, NJ, USA. 2004.
  58. Lilford RJ, Thornton JG, Braunholtz D. Clinical trials and rare diseases: a way out of a conundrum. BMJ1995; 311:1621-1625. [PubMed: 8555809]
  59. Edwards SJL, Lilford RJ, Braunholtz D, et al.Why "underpowered" trials are not necessarily unethical. Lancet1997;350:804-807. [PubMed: 9298015]
  60. Yarnell CJ, Abrams D, Baldwin MR, et al., Clinical trials in critical care: can a Bayesian approach enhance clinical and scientific decision making?Lancet Respir Med2020 doi: 10.1016/ S2213-2600(20)30471-9.
  61. Sinclair JC, Haughton DE, Bracken MB, et al.Cochrane neonatal systematic reviews: a survey of the evidence for neonatal therapies. Clin Perinatol20036;30(2):285-230 [PubMed: 12875355]
  62. Wang R, Lagakos SW, Ware JH, et al.Statistics in medicine -reporting subgroup analyses in clinical trials. N Engl J Med2007;357:2189-2194. [PubMed: 18032770]
  63. Schandelmaier S, Briel M, Varadhan R, et al., Development of the instrument to assess the credibility of effect modification analyses (ICEMAN) in randomized controlled trials and meta analyses. CMAJ2020;192:E901-906.--[PubMed: 32778601]
  64. Rothwell PM. Subgroup analysis in randomized controlled trials: importance, indications, and interpretation. Lancet2005;365:176-186. [PubMed: 15639301]
  65. Assmann SF, Pocock SJ, Enos LE, et al.Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet2000;355:1064-1069. [PubMed: 10744093]
  66. Wasserstein RL, Schirm AL, Lazar NA. Moving to a world beyond "p < 0.05". The American Statistician2019;73: No. Sup1, 1-19.
  67. Amrhein V, Greenland S, McShane B. Scientists rise up against statistical significance. Nature2019; 567:305-307 [PubMed: 30894741]
  68. Doyle LW, Cheong JL, Ehrenkranz RA, et al.Late (>7 days) systemic postnatal corticosteroids for prevention of bronchopulmonary dysplasia in preterm infants. Cochrane Database Syst Rev. 20171024;10(10):CD001145. [PubMed: 29063594]
  69. Doyle LW, Halliday HL, Ehrenkranz RA, et al.An update on the impact of postnatal systemic corticosteroids on mortality and cerebral palsy in preterm infants: effect modification by risk of bronchopulmonary dysplasia. J Pediatr2014;165:1258-1260. [PubMed: 25217197]
  70. Quiroz HJ, Rao K, Brady AC, et al., Protocol-driven surgical care of necrotizing enterocolitis and spontaneous intestinal perforation. J Surg Res2020;255:396-404. [PubMed: 32615312]