1. Initial Laparotomy Versus Peritoneal Drainage in Extremely Low Birthweight Infants With Surgical Necrotizing Enterocolitis or Isolated Intestinal Perforation: A Multicenter Randomized Clinical Trial.
- Author
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Blakely, Martin L, Tyson, Jon E, Lally, Kevin P, Hintz, Susan R, Eggleston, Barry, Stevenson, David K, Besner, Gail E, Das, Abhik, Ohls, Robin K, Truog, William E, Nelin, Leif D, Poindexter, Brenda B, Pedroza, Claudia, Walsh, Michele C, Stoll, Barbara J, Geller, Rachel, Kennedy, Kathleen A, Dimmitt, Reed A, Carlo, Waldemar A, Cotten, C Michael, Laptook, Abbot R, Van Meurs, Krisa P, Calkins, Kara L, Sokol, Gregory M, Sanchez, Pablo J, Wyckoff, Myra H, Patel, Ravi M, Frantz, Ivan D, Shankaran, Seetha, D'Angio, Carl T, Yoder, Bradley A, Bell, Edward F, Watterberg, Kristi L, Martin, Colin A, Harmon, Carroll M, Rice, Henry, Kurkchubasche, Arlet G, Sylvester, Karl, Dunn, James CY, Markel, Troy A, Diesen, Diana L, Bhatia, Amina M, Flake, Alan, Chwals, Walter J, Brown, Rebeccah, Bass, Kathryn D, St Peter, Shawn D, Shanti, Christina M, Pegoli, Walter, Skarda, David, Shilyansky, Joel, Lemon, David G, Mosquera, Ricardo A, Peralta-Carcelen, Myriam, Goldstein, Ricki F, Vohr, Betty R, Purdy, Isabell B, Hines, Abbey C, Maitre, Nathalie L, Heyne, Roy J, DeMauro, Sara B, McGowan, Elisabeth C, Yolton, Kimberly, Kilbride, Howard W, Natarajan, Girija, Yost, Kelley, Winter, Sarah, Colaizy, Tarah T, Laughon, Matthew M, Lakshminrusimha, Satyanarayana, and Higgins, Rosemary D
- Subjects
Perinatal Period - Conditions Originating in Perinatal Period ,Clinical Research ,Infant Mortality ,Rare Diseases ,Digestive Diseases ,Preterm ,Low Birth Weight and Health of the Newborn ,Pediatric ,Clinical Trials and Supportive Activities ,Good Health and Well Being ,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 ,isolated intestinal perforation ,neonatal surgery ,premature infant ,randomized clinical trial ,surgical necrotizing enterocolitis ,Eunice Kennedy Shriver National Institute of Child Health ,Human Development Neonatal Research Network ,Medical and Health Sciences ,Surgery - Abstract
ObjectiveThe 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 dataThe 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.MethodsWe 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.ResultsOf 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
- Published
- 2021