NCT01821287已完成不适用
Nutritional Failure in Infants With Single Ventricle Congenital Heart Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Resting Energy Expenditure (REE) for infants with a single ventricle compared to the age-matched control infants using the analysis of covariance procedure
研究概览
简要总结
The purpose of this study is to understand the causes of growth failure and to define biochemical markers of nutritional failure in patients with single ventricle Congenital Heart Disease (CHD).
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
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CHD infants: Infants with a single ventricle CHD admitted to CCHMC for neonatal medical management or surgical palliation
- •Normal controls: Healthy newborns (full-term infants with no known medical problems) recruited from CCHMC and private practices.
排除标准
- •CHD infants: 1) Premature birth (<36 weeks), 2) Chromosomal abnormalities, 3) Major gastrointestinal, pulmonary or neurologic anomalies
- •Normal controls: 1) Premature birth (<36 weeks), 2) Chromosomal abnormalities, 3) Major gastrointestinal, pulmonary or neurologic anomalies., 4) Cardiovascular anomalies
结局指标
主要结局
Resting Energy Expenditure (REE) for infants with a single ventricle compared to the age-matched control infants using the analysis of covariance procedure
时间窗: At 12 months of age
The following covariates will be considered for inclusion in the model: cardiac diagnoses, measures of cardiac function, hemodynamic measurements, number of parents, and number of siblings living at home. Transformations of REE (e.g. log or rank) may be conducted to satisfy the assumptions of the analysis.
次要结局
- The relationship between REE and weight changes in infants with a single ventricle and control subjects; measures include REE, weight, and z-score (weight for age)(At 12 months of age)
研究者
研究点 (1)
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