Initial Laparotomy Versus Peritoneal Drainage in Extremely Low Birthweight Infants With Surgical Necrotizing Enterocolitis or Isolated Intestinal Perforation: A Multicenter Randomized Clinical Trial
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
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.
Lippincott Williams & Wilkins
Annals of surgery
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, Cotten CM, Laptook AR, Van Meurs KP, Calkins KL, Sokol GM, Sanchez PJ, Wyckoff MH, Patel RM, Frantz ID 3rd, Shankaran S, D'Angio CT, Yoder BA, Bell EF, Watterberg KL, Martin CA, Harmon CM, Rice H, Kurkchubasche AG, Sylvester K, Dunn JCY, Markel TA, Diesen DL, Bhatia AM, Flake A, Chwals WJ, Brown R, Bass KD, St Peter SD, Shanti CM, Pegoli W Jr, 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; Eunice Kennedy Shriver National Institute of Child Health, Human Development Neonatal Research Network. Initial Laparotomy Versus Peritoneal Drainage in Extremely Low Birthweight Infants With Surgical Necrotizing Enterocolitis or Isolated Intestinal Perforation: A Multicenter Randomized Clinical Trial. Ann Surg. 2021 Oct 1;274(4):e370-e380. doi: 10.1097/SLA.0000000000005099. PMID: 34506326; PMCID: PMC8439547.