A Comparison of the Effectiveness of Fortified Skimmed Mother's Milk Versus Specialized Formula in the Management of Chylous Effusion in Infants Following Cardiothoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- To evaluate the time to resolution of chylothorax of infants receiving skimmed mother's milk versus specialized formula.
研究概览
简要总结
The purpose of this study is to determine if the use of fortified skimmed mother's milk is a safe alternative to specialized formula in the treatment of chylothorax following cardiothoracic surgery.
详细描述
A chylothorax is a collection of fluid around the lungs that can occur after cardiac surgery. The fluid contains chyle, a milky fluid consisting of fat droplets. The standard treatment is to feed an infant with a specialized low fat formula for up to 6 weeks until the chest has time to heal. This formula is generally not well tolerated and mother's of our patients have expressed a desire to continue using breast milk. A few case reports have been published, but there have not been any studies to date looking at this. Data will be collected to include information about nutrition, weight gain, teaching needs, surgical, hospital, and discharge information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infant birth to 12 months of age
- •Undergo cardiothoracic surgery
- •Develop a chylous effusion
- •Be a breastfed or formula fed infant
排除标准
- •Infant over 12 months of age
- •Infant in state custody (foster care)
- •Infant with milk protein allergy
- •Infant born with congenital chylothorax
- •Infant who develops chylothorax from other surgeries (non-cardiac
结局指标
主要结局
To evaluate the time to resolution of chylothorax of infants receiving skimmed mother's milk versus specialized formula.
时间窗: up to 2 months from enrollment
Fluid around the lungs is assessed by chest radiographs (x-rays) as per our usual standard of care. Cloudy fluid will be sent for analysis (chylomicrons, cell count, lymphocytes, and triglycerides) to confirm the diagnosis. The date of diagnosis, the date of chest tube removal, and the date of resolution of effusion by chest xrays
次要结局
- To evaluate the technique of skimming and fortifying breast milk(the first 30 days after enrollment)
- To evaluate the recurrence rate of chylous effusion in infants receiving skimmed mother's milk versus specialized formula.(up to 4 months after hospital discharge)
- To compare feeding tolerance, growth, and nutrition in infants who receive fortified skimmed mother's milk versus specialized formula(2 months)
研究者
Cindi Farnstrom
Certified Pediatric Nurse Practitioner
Oregon Health and Science University