A Pilot Study of Pulmonary Function in Dysphagic Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- infant pulmonary function test results
研究概览
简要总结
Infants less than 2 years old who have been newly diagnosed with problems swallowing will have pulmonary function tests performed to try to detect the presence of chronic lung disease. Six months later after the infants have received appropriate therapy for their swallowing problems, pulmonary function tests will be performed again to see if there has been any change in their chronic lung disease.
详细描述
Twenty-five infants between the ages of 1 month and 24 months who have just been diagnosed with dysphagia via a modified barium feeding study will be recruited into the study. The infants will be sedated with chloral hydrate and have pulmonary functions measured (pre- and post-bronchodilator spirometry and lung volume) using the infant pulmonary laboratory. Treatment for the infants' dysphagia/chronic aspiration will be treated as determined by the primary care physicians. Six months later the infants will again be sedated and have pulmonary functions measured. Results of the two sets of tests will be compared statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 1 Month 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •infants between ages 1-24 months who have been newly diagnosed with dysphagia
排除标准
- •cystic fibrosis
- •obstructive sleep apnea
- •allergy or adverse reaction to chloral hydrate
- •heart disease
- •liver disease
- •kidney disease
- •pneumonia
- •pleural effusion
- •neuromuscular disease
- •major congenital anomalies
- •tracheoesophageal fistula
- •vascular ring
- •bronchopulmonary dysplasia
- •pharyngeal anomalies
- •Arnold-Chiari malformation
结局指标
主要结局
infant pulmonary function test results
时间窗: On admission to study and 6 months later
次要结局
未报告次要终点
研究者
James D. Tutor, M.D.
James D. Tutor, M.D.
University of Tennessee