Immunoreactive Trypsinogen in Infants With Intestinal Perforation
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To determine the onset and duration of elevation in serum IRT in infants with intestinal perforation.
研究概览
简要总结
This study is designed to evaluate a novel tool to aid in the diagnosis of intestinal perforation in infants who are at high risk. Analysis of perforation rates of all infants in the three largest participating sites shows that the majority of infants with perforation will do so prior to day of life 21. This study will target the group of infants at highest risk for IP, those with birth weight less than 1000 grams, within the time frame most likely to capture the perforation. Hypothesis: An IRT value exists that can adequately differentiate premature infants with and without intestinal perforation in the first 3 weeks of life.
详细描述
At least 300 infants age 1-16 days will be enrolled. IRT values will be obtained daily through day of life 21, if the infant is already having labs drawn that day. The primary outcomes will be intestinal perforation and/or death on or before day of life 21. Each patient will be followed until death or discharge. Discharge will be defined as the release of the infant to home. Infants who are transferred to another NICU may be followed if the receiving NICU is one of the investigational sites. Transfer includes the release of the infant to outside units or other units within the same hospital. The purpose of this follow up is to obtain serial IRT values through day of life 21.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 16 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Informed consent
- •Birth weight less than 1000 grams
- •Admitted to investigative site within first 16 days of life.
排除标准
- •Evidence of Intestinal perforation in utero
- •Suspected or confirmed custic fibrosis
- •Abdominal wall defect or intestinal atresia
- •Concomitant medical condition that may create an unacceptable risk.
结局指标
主要结局
To determine the onset and duration of elevation in serum IRT in infants with intestinal perforation.
时间窗: 3 years
次要结局
- Determine if factors other than intestinal perforation affect serum IRT.(3 years)
研究者
Nicole Birge
Prinicpal Investigator
Children's Hospitals and Clinics of Minnesota