Initial Laparotomy Versus Peritoneal Drainage in Extremely Low Birthweight Infants With Surgical Necrotizing Enterocolitis or Isolated Intestinal Perforation
Authors: 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 C. Y. , 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 , Higgins Rosemary D. 
Published: July 2021

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.