Comparative Effectiveness Trial of Bowel Ultrasound and Abdominal Radiograph Versus Abdominal Radiograph Alone for Diagnosis of Necrotizing Enterocolitis
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
- 否
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
Sherwin Chan MD PhD
Pediatric Radiologist
Children's Mercy Hospital Kansas City
