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临床试验/NCT01223261
NCT01223261已完成不适用

Observational Study of Surgical Treatment of Necrotizing Enterocolotis or Isolated Intestinal Perforation

NICHD Neonatal Research Network17 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2001年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
156
试验地点
17
主要终点
Feasibility of conducting a randomized trial

研究概览

简要总结

The purposes of this study were: 1) to compare mortality and postoperative morbidities in extremely low birth weight (ELBW) infants who underwent initial laparotomy or drainage for necrotizing enterocolitis (NEC) or isolated intestinal perforation (IP); 2) to determine the ability to distinguish NEC from IP preoperatively and the importance of this distinction on outcome measures; and 3) to evaluate the association between extent of intestinal disease determined at operation and outcome measures. All ELBW infants born at participating NRN centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon and neonatologist to require surgical intervention. Data were collected enrolled infants, including: intraoperative findings recorded by the surgeon and specific post-operative complications. Neurodevelopmental examinations were conducted on surviving infants at 18-22 months corrected age.

详细描述

Necrotizing enterocolitis (NEC) is a condition, generally affecting premature infants, in which the intestines become ischemic (lack oxygen and/or blood flow). NEC occurs in up to 5-15% of extremely low birth weight (ELBW) infants. Isolated or focal intestinal perforation (IP) is a less common condition, affecting an estimated 4% of ELBWs, in which a hole develops in the intestines leaking fluid into the abdomin. The outcomes for infants with NEC or IP are poor: 49% die and half of the surviving infants are neurodevelopmentally impaired.

Surgical options for NEC and IP include two possible procedures: peritoneal drainage, in which a tube is placed in the abdominal cavity through a small incision for fluid to drain out; or laparotomy, in which an incision is made in the abdomen and diseased intestine is removed. Infants treated with an initial drainage sometimes go on to need a laparotomy. Most surgeons now believe that a diagnosis of the intestinal perforation (IP) may actually be either true NEC or a different and distinct pathology, termed isolated intestinal perforation. The ability to distinguish these 2 conditions preoperatively, based on perinatal characteristics, physical examination findings, and findings on abdominal plain film imaging, remains unknown. If these 2 entities can be distinguished preoperatively, the intervention chosen and outcomes may be different. From the two available surgical options, tt is not known whether initial laparotomy or peritoneal drain placement is more effective for either NEC or IP.

This study was a prospective, multicenter observational study to describe the surgical outcomes (mortality, post-operative intestinal stricture, intra-abdominal abscess formation, etc.) in ELBW infants with either NEC or IP who underwent initial laparotomy or peritoneal drainage. We also evaluated the ability of surgeons to distinguish NEC and IP pre-operatively and the relevance of this distinction on outcome. Finally, an analysis of the impact of extent of intestinal involvement with NEC on outcome measures is reported.

All ELBW infants born at participating NRN centers were screened for the presence of NEC or IP that was thought by the pediatric surgeon and neonatologist to require surgical intervention. Data were collected enrolled infants, including: intraoperative findings recorded by the surgeon and specific post-operative complications.

Neurodevelopmental examinations were conducted on surviving infants at 18-22 months corrected age.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 6 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born 401-1,000 grams at birth enrolled in the NRN Generic Database
  • Sage III NEC or isolated intestinal perforation
  • Pediatric surgeon decision to perform surgery for suspected NEC or IP

排除标准

  • Decision not to treat

结局指标

主要结局

Feasibility of conducting a randomized trial

时间窗: 1 year

Ability to enroll infants in a 1-year period

次要结局

  • Frequency of postoperative complications(Until hospital discharge or 120 days of life)
  • Neurodevelopmental impairment(18-22 months corrected age)
  • Document variation in current surgical practices(Until hospital discharge or 120 days of life)
  • Prevalence of infants who would qualify for the study(Until hospital discharge or 120 days of life)

研究者

发起方
NICHD Neonatal Research Network
申办方类型
Network

研究点 (17)

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