Automated Infrared Imaging Tools for Discerning Necrotizing Enterocolitis From Normal Abdominal Thermograms: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Region of interest inclusion
研究概览
简要总结
Necrotizing enterocolitis (NEC) is a devastating disease affecting the intestines of premature infants. It involves intestine swelling, tissue destruction, infection, and even death. Improved outcome is highly dependent on early recognition and treatment, however the signs and symptoms of NEC in early stages are not obvious making it difficult to diagnose. Abdominal x-rays and ultrasound can be non-specific and may not show signs of the disease until late in its course.
Infrared imaging is a non-invasive, non-radiation method that can measure the heat given off of the surface of the body and create heat maps. It is being used clinically in other situations but is still under investigation for use in preterm infants with suspected NEC. Computer analysis of the measured heat maps can be used to detect changes in the intestine such as the swelling or tissue destruction involved in NEC.
Our group has previously performed a pilot study that showed that infrared imaging on babies in the NICU can be used to create heat maps that are different between normal babies and those with NEC when analyzed using specialized computer programs. In this study the investigators will improve the imaging process by using special vision sensors to automate the imaging process and make it easier for bedside staff to use this technology. Special programs will be developed to automatically select areas of interest over which temperature maps will be analyzed. The investigators will use this new imaging technique to study a population of newborns diagnosed with definitive NEC and a healthy population of newborns without NEC, and compare the heat maps obtained from each group. From the analysis of the images obtained from these two populations, the investigators will determine the suitability and necessary fine-tuning of this new imaging technique with the hopes that this technology can someday aid in the early diagnosis of NEC.
详细描述
Background information about NEC:
The best prognosis requires early recognition and treatment of NEC. Perforation or ongoing deterioration may require surgical intervention. Mortality has improved in recent years but is still about 15-30 % for non-surgical NEC and up to 50% for surgical NEC. Survivors may suffer significant complications including long-term damage to bowel function.
The initial diagnosis is based on clinical exam and diagnostic imaging, usually involving abdominal x-rays +/- ultrasound. Bell's staging criteria incorporates clinical, laboratory, and radiographic findings, and is used to discern suspected NEC from definitive NEC. Bell's stage 2 denotes proven NEC and involves the presence of pneumatosis intestinalis and/or portal venous gas on x-ray.
The main difficulty when diagnosing NEC is that early/suspected stages of NEC present clinically and radiographically in a similar way to benign feeding intolerance seen with prematurity. Abdominal x-rays involve exposure of the patient to ionizing radiation and ultrasound imaging is disruptive to the patient, takes time to perform, and requires skilled operators who have limited availability. These modalities will only show non-specific changes in early stages of NEC. Late findings are more discerning, however by the time these findings are apparent the optimal time frame to initiate treatment is often missed.
Background Information About Medical Thermography:
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
- 26 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Babies who are 26+0 - 42+0 weeks corrected gestational age and are admitted to the CHEO or TOH-GC NICU.
- •Diagnosed with definitive, minimum Bell's stage 2 necrotizing enterocolitis
- •In stable condition (with respect to respiratory status, heart rate, blood pressure, oxygen saturation and pain control) as determined by the study physician.
- •Normal Group:
- •Babies born at 26+0 - 42+0 weeks gestation who are admitted to the CHEO or TOH-GC NICU.
- •No clinical or radiological, signs commonly associated with necrotizing enterocolitis, no diagnosis of clinical sepsis or hypotension.
- •In stable condition (with respect to respiratory status, heart rate, blood pressure, oxygen saturation and pain control) as determined by the study physician.
排除标准
- •Any baby with a known congenital anomaly involving the intra-abdominal organs or abdominal wall.
- •Any baby with umbilical lines, tapes, or dressings applied to the abdomen that will obscure the thermographic imaging.
- •Any baby who has had abdominal surgery within the previous 7 days.
- •Any baby deemed to be clinically unstable by the bedside nursing/physician team or the study physician will be excluded from enrollment.
结局指标
主要结局
Region of interest inclusion
时间窗: 2 years
Categorization of heat map as either "complete" or "incomplete" based on the inclusion of the entire abdominal region of interest being captured by our automated thermographic imaging system.
次要结局
- Accurate classification of heat distribution maps as NEC versus Normal(2 years)