Surgical decision-making strategies in preterm neonates with necrotizing enterocolitis: A randomized controlled clinical trial

INTRODUCTION: Surgical necrotizing enterocolitis (NEC) is associated with high mortality. Bell's criteria may indicate surgery in late stages, leading to worse outcomes. Early identification of surgical candidates is necessary. Objective: To evaluate surgical decision-making strategies in neonates with NEC, comparing Bell's criteria versus the combined use of metabolic disorder components (MD7) and paracentesis. MATERIAL AND METHODS: A randomized controlled clinical trial was conducted in perinatal hospitals (2022-2023), ClinicalTrials.gov identifier: NCT06035848. Preterm neonates with NEC were divided into a control group (CG): surgery determined by Bell's criteria, and an intervention group (IG): surgery indicated by MD7 and positive paracentesis. The primary outcome was mortality. Descriptive and inferential statistics, relative risk (RR), with 95% confidence interval (CI), and a p-value < 0.05 indicating statistical significance were used. RESULTS: 117 patients participated (CG n = 56, IG n = 61). In surgical NEC, mortality was 32.1% in IG and 64.7% in CG (p = 0.034; RR = 2, 95% CI: 1.1-4.8). In the IG, surgery was performed early, with better outcomes for perforation, intestinal necrosis, and reoperation (p < 0.05). There were no complications derived from paracentesis, and there were 3 non-therapeutic laparotomies in the IG. CONCLUSIONS: The strategy based on MD7 and paracentesis was superior to Bell's criteria for guiding surgical decisions in preterm neonates with NEC, reducing mortality. The main limitation was a small number of non-therapeutic laparotomies, expected due to the greater sensitivity of the strategy.