Martin L Blakely1, Jon E Tyson2, Kevin P Lally3, Susan R Hintz4, Barry Eggleston5, David K Stevenson4, Gail E Besner6, Abhik Das7, Robin K Ohls8,9, William E Truog10, Leif D Nelin11, Brenda B Poindexter12, Claudia Pedroza2, Michele C Walsh13, Barbara J Stoll2, Rachel Geller14, Kathleen A Kennedy2, Reed A Dimmitt15, Waldemar A Carlo15, C Michael Cotten16, Abbot R Laptook17, Krisa P Van Meurs4, Kara L Calkins14, Gregory M Sokol18, Pablo J Sanchez11, Myra H Wyckoff19, Ravi M Patel20, Ivan D Frantz21,22, Seetha Shankaran23, Carl T D'Angio24, Bradley A Yoder9, Edward F Bell25, Kristi L Watterberg8, Colin A Martin26, Carroll M Harmon26,27, Henry Rice28, Arlet G Kurkchubasche29, Karl Sylvester30, James C Y Dunn30,31, Troy A Markel32, Diana L Diesen33, Amina M Bhatia34, Alan Flake35, Walter J Chwals36, Rebeccah Brown37, Kathryn D Bass27, Shawn D St Peter38, Christina M Shanti32, Walter Pegoli39, David Skarda40, Joel Shilyansky41, David G Lemon42, Ricardo A Mosquera2, Myriam Peralta-Carcelen15, Ricki F Goldstein16, Betty R Vohr17, Isabell B Purdy14, Abbey C Hines18, Nathalie L Maitre11, Roy J Heyne19, Sara B DeMauro43, Elisabeth C McGowan17,21, Kimberly Yolton12, Howard W Kilbride10, Girija Natarajan23, Kelley Yost24, Sarah Winter9, Tarah T Colaizy25, Matthew M Laughon44, Satyanarayana Lakshminrusimha24, Rosemary D Higgins45,46. 1. Department of Pediatric Surgery, Vanderbilt University Medical Center, Nashville, TN. 2. Department of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX. 3. Department of Pediatric Surgery, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX. 4. Department of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA. 5. Social, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, NC. 6. Department of Pediatric Surgery, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH. 7. Social, Statistical and Environmental Sciences Unit, RTI International, Research Rockville, MD. 8. University of New Mexico Health Sciences Center, Albuquerque, NM. 9. Department of Pediatrics, Division of Neonatology, University of Utah School of Medicine, Salt Lake City, UT. 10. Department of Pediatrics, Children's Mercy Hospital, Kansas City, MO. 11. Department of Pediatrics, Nationwide Children's Hospital, The Ohio State University College of Medicine, Columbus, OH. 12. Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH. 13. Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH. 14. Department of Pediatrics, University of California, Los Angeles, CA. 15. Division of Neonatology, University of Alabama at Birmingham, Birmingham, AL. 16. Department of Pediatrics, Duke University, Durham, ND. 17. Department of Pediatrics, Women's & Infants Hospital, Brown University, Providence, RI. 18. Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN. 19. Department of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX. 20. Emory University School of Medicine, Department of Pediatrics, Children's Healthcare of Atlanta, Atlanta, GA. 21. Department of Pediatrics, Division of Newborn Medicine, Floating Hospital for Children, Tufts Medical Center, Boston, MA. 22. Department of Neonatology, Beth Israel Deaconess Medical Center, Boston, MA. 23. Department of Pediatrics, Wayne State University, Detroit, MI. 24. University of Rochester School of Medicine and Dentistry, Rochester, NY. 25. Department of Pediatrics, University of Iowa, Iowa City, IA. 26. Division of Pediatric Surgery, University of Alabama at Birmingham, Birmingham, AL. 27. Division of Pediatric Surgery, University of Buffalo, John R. Oishei Children's Hospital, Buffalo, NY. 28. Division of Pediatric General Surgery, Duke University, Durham, NC. 29. Department of Pediatric Surgery, Hasbro Children's Hospital, Brown University, Providence, RI. 30. Department of Pediatric Surgery, Stanford University School of Medicine, Palo Alto, CA. 31. Department of Pediatric Surgery, University of California, Los Angeles, CA. 32. Department of Pediatric Surgery, Indiana University School of Medicine, Indianapolis, IN. 33. Department of Pediatric Surgery, University of Texas Southwestern Medical Center, Dallas, TX. 34. Department of Pediatric Surgery, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA. 35. Department of Pediatric Surgery, University of Pennsylvania, Philadelphia, PA. 36. Department of Pediatric Surgery, Floating Hospital for Children, Tufts Medical Center, Boston, MA. 37. Department of Pediatric Surgery, Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, OH. 38. Department of Pediatric Surgery, Children's Mercy Hospital, Kansas City, MO. 39. Department of Pediatric Surgery, University of Rochester School of Medicine and Dentistry, Rochester, NY. 40. Department of Pediatric Surgery, University of Utah School of Medicine, Salt Lake City, UT. 41. Department of Surgery, University of Iowa, Iowa City, IA. 42. Department of Pediatric Surgery, University of New Mexico Health Sciences Center, Albuquerque, NM. 43. Department of Pediatrics, University of Pennsylvania, Philadelphia, PA. 44. Division of Neonatal/Perinatal Medicine, Department of Pediatrics, University of North Carolina, Chapel Hill, NC. 45. Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD. 46. College of Health and Human Services, George Mason University, Fairfax, VA.
Abstract
OBJECTIVE: The aim of this study was to determine which initial surgical treatment results in the lowest rate of death or neurodevelopmental impairment (NDI) in premature infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP). SUMMARY BACKGROUND DATA: The impact of initial laparotomy versus peritoneal drainage for NEC or IP on the rate of death or NDI in extremely low birth weight infants is unknown. METHODS: We conducted the largest feasible randomized trial in 20 US centers, comparing initial laparotomy versus peritoneal drainage. The primary outcome was a composite of death or NDI at 18 to 22 months corrected age, analyzed using prespecified frequentist and Bayesian approaches. RESULTS: Of 992 eligible infants, 310 were randomized and 96% had primary outcome assessed. Death or NDI occurred in 69% of infants in the laparotomy group versus 70% with drainage [adjusted relative risk (aRR) 1.0; 95% confidence interval (CI): 0.87-1.14]. A preplanned analysis identified an interaction between preoperative diagnosis and treatment group (P = 0.03). With a preoperative diagnosis of NEC, death or NDI occurred in 69% after laparotomy versus 85% with drainage (aRR 0.81; 95% CI: 0.64-1.04). The Bayesian posterior probability that laparotomy was beneficial (risk difference <0) for a preoperative diagnosis of NEC was 97%. For preoperative diagnosis of IP, death or NDI occurred in 69% after laparotomy versus 63% with drainage (aRR, 1.11; 95% CI: 0.95-1.31); Bayesian probability of benefit with laparotomy = 18%. CONCLUSIONS: There was no overall difference in death or NDI rates at 18 to 22 months corrected age between initial laparotomy versus drainage. However, the preoperative diagnosis of NEC or IP modified the impact of initial treatment.
OBJECTIVE: The aim of this study was to determine which initial surgical treatment results in the lowest rate of death or neurodevelopmental impairment (NDI) in premature infants with necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP). SUMMARY BACKGROUND DATA: The impact of initial laparotomy versus peritoneal drainage for NEC or IP on the rate of death or NDI in extremely low birth weight infants is unknown. METHODS: We conducted the largest feasible randomized trial in 20 US centers, comparing initial laparotomy versus peritoneal drainage. The primary outcome was a composite of death or NDI at 18 to 22 months corrected age, analyzed using prespecified frequentist and Bayesian approaches. RESULTS: Of 992 eligible infants, 310 were randomized and 96% had primary outcome assessed. Death or NDI occurred in 69% of infants in the laparotomy group versus 70% with drainage [adjusted relative risk (aRR) 1.0; 95% confidence interval (CI): 0.87-1.14]. A preplanned analysis identified an interaction between preoperative diagnosis and treatment group (P = 0.03). With a preoperative diagnosis of NEC, death or NDI occurred in 69% after laparotomy versus 85% with drainage (aRR 0.81; 95% CI: 0.64-1.04). The Bayesian posterior probability that laparotomy was beneficial (risk difference <0) for a preoperative diagnosis of NEC was 97%. For preoperative diagnosis of IP, death or NDI occurred in 69% after laparotomy versus 63% with drainage (aRR, 1.11; 95% CI: 0.95-1.31); Bayesian probability of benefit with laparotomy = 18%. CONCLUSIONS: There was no overall difference in death or NDI rates at 18 to 22 months corrected age between initial laparotomy versus drainage. However, the preoperative diagnosis of NEC or IP modified the impact of initial treatment.
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Authors: Peter McCulloch; Douglas G Altman; W Bruce Campbell; David R Flum; Paul Glasziou; John C Marshall; Jon Nicholl; Jeffrey K Aronson; Jeffrey S Barkun; Jane M Blazeby; Isabell C Boutron; W Bruce Campbell; Pierre-Alain Clavien; Jonathan A Cook; Patrick L Ergina; Liane S Feldman; David R Flum; Guy J Maddern; Jon Nicholl; Bournaby C Reeves; Christoph M Seiler; Steven M Strasberg; Jonathan L Meakins; Deborah Ashby; Nick Black; John Bunker; Martin Burton; Marion Campbell; Kalipso Chalkidou; Iain Chalmers; Marc de Leval; Jon Deeks; Patrick L Ergina; Adrian Grant; Muir Gray; Roger Greenhalgh; Milos Jenicek; Sean Kehoe; Richard Lilford; Peter Littlejohns; Yoon Loke; Rajan Madhock; Kim McPherson; Jonathan Meakins; Peter Rothwell; Bill Summerskill; David Taggart; Parris Tekkis; Matthew Thompson; Tom Treasure; Ulrich Trohler; Jan Vandenbroucke Journal: Lancet Date: 2009-09-26 Impact factor: 79.321
Authors: Edward F Bell; Barbara J Stoll; Nellie I Hansen; Myra H Wyckoff; Michele C Walsh; Pablo J Sánchez; Matthew A Rysavy; Jenna H Gabrio; Stephanie W Archer; Abhik Das; Rosemary D Higgins Journal: Semin Perinatol Date: 2022-06-10 Impact factor: 3.311
Authors: Martin L Blakely; Matthew A Rysavy; Kevin P Lally; Barry Eggleston; Claudia Pedroza; Jon E Tyson Journal: Semin Perinatol Date: 2022-06-10 Impact factor: 3.311