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临床试验/NCT05573113
NCT05573113已完成不适用

Comparative Effectiveness Trial of Bowel Ultrasound and Abdominal Radiograph Versus Abdominal Radiograph Alone for Diagnosis of Necrotizing Enterocolitis

Children's Mercy Hospital Kansas City4 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
169
试验地点
4
主要终点
Days to Full Enteral Feeds: Extended Rule Out Group

研究概览

简要总结

The overall objective of our study is to determine the clinical usefulness of BUS for NEC evaluation in diverse NICU settings.

详细描述

Bowel ultrasound (BUS) for NEC evaluation is a non-invasive imaging modality that allows real-time assessment of the intestinal wall, vascular perfusion, peristalsis, and abdominal fluid. Advantages of BUS is it is non-invasive, does not have radiation, does not require special preparation before procedure, and is well tolerated even by sick preterm infants. BUS is already being used in centers that have sufficient BUS expertise as an alternative standard of care approach for evaluating NEC, but in a highly variable manner.

Standard ultrasound equipment is all that is needed for BUS. Pre-study training will be conducted for sonographers to acquire the study BUS images using standardized technique. Pre-study training of radiologists will also be conducted to standardize the interpretation of BUS findings for NEC. All BUS for NEC ordering, acquisition, and interpretation in the study will be the same as the standard workflow for any other imaging ordered in the clinical setting. All BUS performed as part of the study will not be charged to patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 1 Year(Child)
性别
All
接受健康志愿者

入选标准

  • Admitted to the NICU at CMKC or KUMC
  • With clinical suspicion for NEC for which further imaging evaluation was decided by treating neonatologist

排除标准

  • Infants with major gastrointestinal anomalies such as gastroschisis or omphalocele that prevent BUS from being performed

结局指标

主要结局

Days to Full Enteral Feeds: Extended Rule Out Group

时间窗: Within 30 days of NEC concern

Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds

Days to Full Enteral Feeds: NEC Ruled In

时间窗: Within 30 days of NEC concern

Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds

Days to Full Enteral Feeds: Quick Rule Out Group

时间窗: Within 30 days of NEC concern

Number of days for infants to tolerate at least 120 mL/kg/day of enteral feeds

次要结局

  • Days to End Bowel Rest: Quick Rule Out Group(within 14 days of NEC concern)
  • Days to End Antibiotics: Quick Rule Out(within 14 days of NEC concern)
  • Days to End Antibiotics: NEC Rule In(within 14 days of NEC concern)
  • Days to End Bowel Rest: Extended Rule Out Group(within 14 days of NEC concern)
  • Days to End Bowel Rest: NEC Ruled In(within 14 days of NEC concern)
  • Days to End Antibiotics: Extended Rule Out(within 14 days of NEC concern)

研究者

发起方
Children's Mercy Hospital Kansas City
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherwin Chan MD PhD

Pediatric Radiologist

Children's Mercy Hospital Kansas City

研究点 (4)

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