Biomarkers for Feeding Intolerance in Infants With Complex Congenital Heart Defects Undergoing Single Ventricle Staged Palliation
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Level of second most abundant serum protein as determined by ELISA
研究概览
简要总结
The purpose of this study is to investigates serum and stool biomarkers as predictors for post-operative feeding intolerance in infant patients with complex congenital heart defects who undergo single ventricle staged palliation surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Full term gestational period (37 weeks gestation or greater)
- •minimum of 2.5kg or greater body weight
- •diagnosis of single ventricle physiology, or complex congenital cyanotic heart disease requiring staged palliation surgery in the form of Norwood-type procedure, systemic-to-pulmonary artery shunt, or pulmonary artery banding.
排除标准
- •Have diseases affecting other organs,
- •have major congenital anomalies such as Hirschsprung disease, imperforate anus, CHARGE syndrome, or VACTERL association.
结局指标
主要结局
Level of second most abundant serum protein as determined by ELISA
时间窗: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
Level of stool biomarker interleukin-8 (IL-8) as determined by ELISA
时间窗: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
Level of most abundant serum protein as determined by ELISA
时间窗: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
We will select two proteins with top changes that are involved in the pathways for intestinal inflammation, and levels will be determined with either ELISA or other techniques that are available.
Level of stool biomarker calprotectin as determined by ELISA
时间窗: baseline (3-5 days after initial cardiac surgery), within three weeks of the initial cardiac surgery
次要结局
未报告次要终点
研究者
Supriya Nair
Pediatric GI Fellow
The University of Texas Health Science Center, Houston