Title | Initial Laparotomy Versus Peritoneal Drainage in Extremely Low Birthweight Infants With Surgical Necrotizing Enterocolitis or Isolated Intestinal Perforation: A Multicenter Randomized Clinical Trial. |
Publication Type | Journal Article |
Year of Publication | 2021 |
Authors | Blakely ML, Tyson JE, Lally KP, Hintz SR, Eggleston B, Stevenson DK, Besner GE, Das A, Ohls RK, Truog WE, Nelin LD, Poindexter BB, Pedroza C, Walsh MC, Stoll BJ, Geller R, Kennedy KA, Dimmitt RA, Carlo WA, C Cotten M, Laptook AR, Van Meurs KP, Calkins KL, Sokol GM, Sánchez PJ, Wyckoff MH, Patel RM, Frantz ID, Shankaran S, D'Angio CT, Yoder BA, Bell EF, Watterberg KL, Martin CA, Harmon CM, Rice H, Kurkchubasche AG, Sylvester K, C Y Dunn J, Markel TA, Diesen DL, Bhatia AM, Flake A, Chwals WJ, Brown R, Bass KD, St Peter SD, Shanti CM, Pegoli W, Skarda D, Shilyansky J, Lemon DG, Mosquera RA, Peralta-Carcelen M, Goldstein RF, Vohr BR, Purdy IB, Hines AC, Maitre NL, Heyne RJ, DeMauro SB, McGowan EC, Yolton K, Kilbride HW, Natarajan G, Yost K, Winter S, Colaizy TT, Laughon MM, Lakshminrusimha S, Higgins RD |
Corporate Authors | Eunice Kennedy Shriver National Institute of Child Health, Human Development Neonatal Research Network |
Journal | Ann Surg |
Volume | 274 |
Issue | 4 |
Pagination | e370-e380 |
Date Published | 2021 10 01 |
ISSN | 1528-1140 |
Keywords | Drainage, Enterocolitis, Necrotizing, Feasibility Studies, Female, Humans, Infant, Extremely Low Birth Weight, Infant, Newborn, Infant, Premature, Infant, Premature, Diseases, Intestinal Perforation, Laparotomy, Male, Neurodevelopmental Disorders, Survival Rate, Treatment Outcome |
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. |
DOI | 10.1097/SLA.0000000000005099 |
Alternate Journal | Ann Surg |
PubMed ID | 34506326 |
PubMed Central ID | PMC8439547 |
Grant List | UG1 HD068263 / HD / NICHD NIH HHS / United States U10 HD021373 / HD / NICHD NIH HHS / United States UL1 RR025764 / RR / NCRR NIH HHS / United States UG1 HD068270 / HD / NICHD NIH HHS / United States UG1 HD027856 / HD / NICHD NIH HHS / United States UG1 HD034216 / HD / NICHD NIH HHS / United States UG1 HD027880 / HD / NICHD NIH HHS / United States UG1 HD053109 / HD / NICHD NIH HHS / United States UG1 HD027851 / HD / NICHD NIH HHS / United States U10 HD036790 / HD / NICHD NIH HHS / United States UG1 HD068278 / HD / NICHD NIH HHS / United States UG1 HD087226 / HD / NICHD NIH HHS / United States U10 HD053124 / HD / NICHD NIH HHS / United States U10 HD053119 / HD / NICHD NIH HHS / United States U01 HD036790 / HD / NICHD NIH HHS / United States UG1 HD068244 / HD / NICHD NIH HHS / United States UG1 HD027853 / HD / NICHD NIH HHS / United States UL1 TR000042 / TR / NCATS NIH HHS / United States UL1 TR000006 / TR / NCATS NIH HHS / United States UG1 HD040689 / HD / NICHD NIH HHS / United States UG1 HD053089 / HD / NICHD NIH HHS / United States UL1 TR000093 / TR / NCATS NIH HHS / United States UL1 TR000454 / TR / NCATS NIH HHS / United States U10 HD027871 / HD / NICHD NIH HHS / United States UG1 HD027904 / HD / NICHD NIH HHS / United States UL1 TR000142 / TR / NCATS NIH HHS / United States UL1 TR000041 / TR / NCATS NIH HHS / United States UG1 HD068284 / HD / NICHD NIH HHS / United States UG1 HD021385 / HD / NICHD NIH HHS / United States UG1 HD040492 / HD / NICHD NIH HHS / United States UG1 HD021364 / HD / NICHD NIH HHS / United States UL1 TR001117 / TR / NCATS NIH HHS / United States UL1 TR000077 / TR / NCATS NIH HHS / United States |