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临床试验/NCT02143557
NCT02143557已完成不适用

The Effectiveness of Low Fat Breast Milk for the Treatment of Chylothorax in Infants Following Cardiothoracic Surgery: A Pilot Study

The Hospital for Sick Children2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2008年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
2
主要终点
Chyle Drainage from Chest Tubes

研究概览

简要总结

Chylothorax occurs in ~3 to 5 % of infants undergoing cardiac surgery. Standard treatment requires discontinuation of breast milk feeding, due to the abundance of long chain triglycerides, and transition to a medium chain triglyceride (MCT) based formula. Objective: To determine the effectiveness of fat-modified breast milk (MBM) for the treatment of chylothorax compared with MCT-formula. Hypothesis: The investigators primary hypothesis was that infants fed MBM would have more chyle drainage in the first 5 days after diagnosis compared to infants fed an MCT based formula which is the current standard of care. Design: Infants with chylothorax were eligible. Treatment infants (n=8) received mother's own milk that had been modified by removing the fat layer via centrifugation and adding MCT and nutrients to provide 67 kcal/mL and 11 g/100 mL protein (MBM group). Control infants (n=8) received an MCT-formula (MCT group). The feeding intervention was a minimum of 6 weeks after chest tube removal per The Hospital for Sick Children standard chylothorax treatment protocol. Outcome measures collected included chyle drainage from chest tubes, weight, length and head circumference measurements and estimated energy and nutrient intake.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
— 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Infants < 12 months of age who were diagnosed with chylothorax.
  • Infants included in the intervention group (MBM) needed to have received >80% of their enteral feeds as breast milk prior to surgery.
  • Infants included in the control group (MCT-formula) needed to have received <80% of their enteral feeds as breast milk prior to surgery.

排除标准

  • Subjects were excluded if their diagnosis made it unlikely that they would be able to follow the hospital's standard 6 week protocol for treatment of chylothorax
  • Were receiving only parenteral nutrition at the time of diagnosis of chylothorax
  • Primary caregiver of the baby did not have good comprehension of English.

结局指标

主要结局

Chyle Drainage from Chest Tubes

时间窗: 6 weeks of chylothorax treatment

This outcome includes measurement of chyle drainage from chest tubes in the first 5 days after diagnosis of chylothorax and the number of days of chest tube drainage.

次要结局

  • Growth(6 weeks of the chylothorax treatment)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Deborah O'Connor

Senior Associate Scientist

The Hospital for Sick Children

研究点 (2)

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