Neu Josef, Singh Rachana, Demetrian Mihaela, Flores-Torres Jaime, Hudak Mark, Zupancic John A, Kronström Anders, Rastad Jonas, Strömberg Staffan, Thuresson Marcus
Department of Pediatrics, UF Health Shands Children's Hospital, Gainesville, Florida.
Department of Pediatrics, Tuft's Children's Hospital, Tuft's University School of Medicine, Boston, Massachusetts.
Am J Perinatol. 2025 Jan;42(2):268-280. doi: 10.1055/s-0044-1788275. Epub 2024 Jul 10.
Necrotizing enterocolitis (NEC) classically is diagnosed by radiographic demonstration of pneumatosis intestinalis/portal venous gas (PI/PVG). This study examines clinical characteristics of NEC confirmed by independent evaluation of abdominal radiographs, taken for clinical signs of NEC, or by pathologic findings at laparotomy or autopsy (confirmed NEC [cNEC]).
The investigated cohort included 1,382 extremely low birth weight (BW) infants (BW range: 500-1,000 g) with median 27 weeks (range: 23-32) gestational age (GA) at birth. They were randomized into the placebo-controlled "Connection Trial" of the new biological drug candidate IBP-9414 with cNEC as one primary endpoint.
Total 119 infants (8.6%) had cNEC diagnosed at median 14 days of age by confirming PI/PVG at X-ray adjudication ( = 111) and/or by surgery/autopsy ( = 21). Sixteen percent of cNEC cases died. Adverse events of NEC were reported in 8.5% of infants and 4.1% had NEC diagnosed by radiology and surgery/autopsy at the participating centers. Regression analyses showed that the risk of cNEC decreased by 11 to 30% for every 100-g increment in BW and single-week increment in GA and associated cNEC with odds ratios (ORs) > 2.0 for gastrointestinal (GI) perforation and obstruction, hypotension, hypokalemia, hypophosphatemia, and death. Comparing risks of cNEC in infants below and above 750-g BW showed higher ORs (2.7-4.3) for GI perforation, hypotension, hypokalemia, and renal complications in the smaller infants, whereas the bigger infants had higher ORs (1.9-3.2) for serious non-GI events, late-onset sepsis (LOS), and death. Predictors of cNEC (hazard ratio, HR > 1.5) included serious non-GI events (mainly infections), hyponatremia, and hyperglycemia, whereas the HR was 0.52 for intravenous antibiotics. After cNEC diagnosis, there were higher rates of GI perforation and obstruction, hypotension, hypokalemia, and LOS.
Independent adjudication of abdominal radiographs increased radiological recognition of NEC and proved to be feasible in a multicenter study setting as well as able to diagnose clinically relevant NEC.
· Independent adjudication of abdominal radiographs in ELBW infants increased NEC recognition.. · Risk of NEC decreased by 11 to 30% with every 100-g increment in BW and GA week.. · In infants with BW 750 to 1,000 g, the risk of death from NEC was almost twice that in infants with BW 500 to 749 g. · Infants with NEC received antibiotics during one-third and parenteral nutrition during half of the first 7 postnatal weeks..
坏死性小肠结肠炎（NEC）的经典诊断方法是通过影像学检查显示肠壁积气/门静脉积气（PI/PVG）。本研究探讨经独立评估腹部X线片（因NEC临床体征而拍摄）或剖腹手术或尸检的病理结果确诊的NEC（确诊NEC [cNEC]）的临床特征。
研究队列包括1382例极低出生体重（BW）婴儿（BW范围：500 - 1000 g），出生时胎龄（GA）中位数为27周（范围：23 - 32周）。他们被随机分为以cNEC为主要终点之一的新型生物候选药物IBP - 9414的安慰剂对照“连接试验”。
共有119例婴儿（8.6%）在年龄中位数为14天时被诊断为cNEC，通过X线判定（n = 111）确认PI/PVG和/或通过手术/尸检（n = 21）确诊。16%的cNEC病例死亡。8.5%的婴儿报告了NEC不良事件，4.1%的婴儿在参与中心通过放射学及手术/尸检诊断为NEC。回归分析显示，BW每增加100 g以及GA每增加1周，cNEC风险降低11%至30%，并且胃肠道（GI）穿孔、梗阻、低血压、低钾血症、低磷血症和死亡的cNEC比值比（OR）> 2.0。比较BW低于和高于750 g的婴儿的cNEC风险，较小婴儿发生GI穿孔、低血压、低钾血症和肾脏并发症的OR较高（2.7 - 4.3），而较大婴儿发生严重非GI事件、迟发性败血症（LOS）和死亡的OR较高（1.9 - 3.2）。cNEC的预测因素（风险比，HR > 1.5）包括严重非GI事件（主要是感染）、低钠血症和高血糖，而静脉使用抗生素的HR为0.52。cNEC诊断后，GI穿孔、梗阻、低血压、低钾血症和LOS的发生率更高。
腹部X线片的独立判定提高了NEC的放射学诊断率，在多中心研究环境中被证明是可行的，并且能够诊断临床相关的NEC。
· 对极低出生体重婴儿的腹部X线片进行独立判定可提高NEC的诊断率。· BW每增加100 g和GA每增加1周，NEC风险降低11%至30%。· BW为750至1000 g的婴儿因NEC死亡的风险几乎是BW为500至749 g婴儿的两倍。· 患有NEC的婴儿在出生后前7周的三分之一时间内接受抗生素治疗，一半时间接受肠外营养。
