Surgical NEC,Randomized Control Trials,Missed Opportunity

Necrotizing enterocolitis (NEC) affects 6-10% of preterm infants with a birth weight of less than 1500 grams [1, 2]. NEC remains a leading cause of death and intestinal failure among preterm neonates, leading to increased hospital care and economic burden [3]. Those infants with NEC who progress to bowel perforation are managed with either primary peritoneal drainage or laparotomy/resection. Despite evaluation of the route of surgical intervention, considerable uncertainty over which procedure is preferable under any specific condition remains [4].

The three major trials to date evaluating the best surgical approach are summarized in Table 1. None of the randomized controlled trials (RCT) report the perioperative clinical status or the duration of medical therapy received prior to surgical Intervention. Additionally, the RCTs do not observe a significant difference in the duration of parenteral nutrition or mortality, though the timing of the surgical intervention relative to the NEC diagnosis and the histopathological diagnosis are not disclosed [5, 6]. Surgical NEC is associated with higher risk of systemic morbidities such as acute kidney injury, white matter injury and bronchopulmonary dysplasia [7–9] and magnified by prolonged inflammation. Given that none of the trials reported on the influence of surgical intervention on these morbidities or others, the capacity for the type of surgical intervention to influence acute or long-term outcomes in infants with NEC is unclear.

A recent population-based, prospective, observational study of all 27 pediatric surgical centers in the United Kingdom and Ireland examined indications for surgical intervention for NEC. The investigators found that “failed” medical management led to a 30-hour delay in surgical time compared to perforation alone. Furthermore, the “failed” medical management was the strongest predictor of parenteral nutrition requirement or death at 28 days post-surgery (OR 4.54 [1.59–13.0] [10]. Similar results were reported by Rees, et al who found that drain placement was a definitive treatment in only 11% of surviving neonates, while the remaining infants treated by primary peritoneal drainage required delayed laparotomy or died [6]. These results suggest that prolonged peritoneal drainage fails to improve the clinical condition of the infants in the long-term. A recent study reported that protocol driven surgical care of preterm infants with surgical NEC had improved the timing and type of the intervention [11]. Further refinement in studies evaluating surgical NEC treatment should include clinical status, timing, and type of intervention – a process best suited to multicenter quality improvement projects (See Table 2). As such, early/earlier intervention in infants with surgical NEC represents an opportunity to maximize both short and long-term outcomes.