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

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.

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.

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.

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.