Analysis of Integrated Clinical, Laboratory and Prognostic Data of Neonates With Necrotizing Enterocolitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Occurrence of perforated necrotizing enterocolitis
研究概览
简要总结
This is a retrospective study led by The Sixth Affiliated Hospital, Sun Yat-sen University, focusing on newborns diagnosed with necrotizing enterocolitis (NEC)-a serious gastrointestinal disease that threatens newborns' lives-between January 2023 and June 2025.
Purpose of the study: NEC can lead to severe conditions like bowel perforation or even death, and it's hard for doctors to spot high-risk babies early with current tools. This study aims to analyze the babies' clinical information (e.g., birth weight, symptoms like belly swelling or bloody stools), blood test results (e.g., lactate levels, white blood cell counts), and organ function scores (nSOFA scores) to find indicators that can predict whether NEC will get worse or cause death.
Questions the study tries to answer: Can combining metabolic indicators (like lactate), blood test parameters, and organ function scores better predict if a newborn with NEC will develop perforated NEC (a more severe form where the bowel has holes) or die during hospitalization? Are these combined indicators more reliable than single indicators alone? Study hypothesis: We guess that integrating metabolic markers (such as lactate), blood routine parameters, and nSOFA scores will be more accurate than using any single indicator to predict the progression of NEC and the risk of death in affected newborns.
详细描述
- Study Rationale Necrotizing Enterocolitis (NEC) is a life-threatening gastrointestinal disorder primarily affecting very low birth weight (VLBW) neonates (incidence: 5-12%). Around 20-40% of cases progress to severe disease requiring surgery, and survivors often face long-term complications (e.g., short-bowel syndrome, neurodevelopmental impairments). Despite advances in neonatal care, early identification of high-risk patients remains challenging due to nonspecific clinical/radiographic signs and insufficiently sensitive/specific conventional biomarkers.
NEC pathophysiology involves intestinal ischemia-reperfusion injury, excessive immune activation, and microbial dysbiosis. Serum lactate (a marker of hypoperfusion/anaerobic metabolism) correlates with NEC severity but lacks specificity; peripheral blood cell (CBC) indices are accessible but understudied in combination with lactate. The Neonatal Sequential Organ Failure Assessment (nSOFA) score predicts overall NEC mortality but fails to stratify risk for perforated NEC (PNEC), a high-risk subtype. This study aims to address gaps by integrating metabolic (lactate), hematologic (CBC), and organ dysfunction (nSOFA) metrics for NEC prognosis. 2. Study Design and Conduct This is a retrospective cohort study conducted at the Sixth Affiliated Hospital, Sun Yat-sen University, approved by the institutional ethics committee and compliant with the Helsinki Declaration. The study period is January 1, 2023-June 30, 2025; eligible participants are identified via retrospective review of electronic medical records (EMRs), with data extracted in a structured manner. 3. Data Collection
Structured EMR extraction captures key variables:
Neonatal history: Sex, gestational age, birth weight, birth asphyxia (Apgar scores), small for gestational age (SGA) status, preterm complications (e.g., patent ductus arteriosus [PDA], respiratory distress syndrome [RDS]), feeding pattern, mechanical ventilation use.
Maternal history: Delivery mode, chorioamnionitis, premature rupture of membranes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 1 Day 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(1) Diagnosis of NEC and having undergone surgical treatment, confirmed by clinical manifestations (e.g., abdominal distension, bloody stools), radiological evidence (pneumatosis intestinalis, portal venous gas, or pneumoperitoneum), and pathological examination in accordance with established guidelines; (2) Availability of complete medical records for data extraction.
排除标准
- •(1) Congenital gastrointestinal malformations (e.g., intestinal atresia, Hirschsprung's disease) or spontaneous intestinal perforation; (2) Hereditary metabolic disorders; (3) Incomplete clinical data or refusal of participation.
研究组 & 干预措施
PNEC group
Perforated necrotizing enterocolitis
干预措施: Observational retrospective cohort study (Other)
Severe NEC group
Bell's stage IIb and III
干预措施: Observational retrospective cohort study (Other)
Mild NEC group
Bell's stage I and IIa
干预措施: Observational retrospective cohort study (Other)
NIP group
non-intestinal perforation in surgical NEC
干预措施: Observational retrospective cohort study (Other)
结局指标
主要结局
Occurrence of perforated necrotizing enterocolitis
时间窗: Day 1 up to 3 months
Occurrence of perforated necrotizing enterocolitis
In-hospital mortality
时间窗: Day 1 up to 3 months
In-hospital mortality
次要结局
- Bell's Staging System for Necrotizing Enterocolitis (NEC)(Day 1 up to 3 months)
- Incidence of Surgical Necrotizing Enterocolitis (NEC)(Day 1 up to 3 months)
研究者
Hu Hao
Professor
Sixth Affiliated Hospital, Sun Yat-sen University