Clinical Trial: Fortified Skimmed Mother's Milk in the Management of Chylothorax

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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

Brief Summary: 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.

Detailed Summary: 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.
Sponsor: Oregon Health and Science University

Current Primary Outcome: To evaluate the time to resolution of chylothorax of infants receiving skimmed mother's milk versus specialized formula. [ Time Frame: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • To evaluate the recurrence rate of chylous effusion in infants receiving skimmed mother's milk versus specialized formula. [ Time Frame: up to 4 months after hospital discharge ]
    All patients receive a standard chest x-ray prior to discharge from the hospital and again in two weeks at their follow up appointment. If symptoms of respiratory difficulty occur prior to or following this time, additional chest x-rays may be obtained based on exam findings and clinical judgment. The date of recurrence of effusion will be recorded as will the date of chest tube insertion if required.
  • To evaluate the technique of skimming and fortifying breast milk [ Time Frame: the first 30 days after enrollment ]
    The skimming technique will be taught to participating mothers and nurses caring for their infants. A sample of the skim milk will be analyzed by a creamatocrit for fat and caloric content.
  • To compare feeding tolerance, growth, and nutrition in infants who receive fortified skimmed mother's milk versus specialized formula [ Time Frame: 2 months ]
    Feeding symptoms observed by clinical staff and parents will be recorded. Parents will complete a questionnaire and score symptoms based on severity. Infants will be monitored as per our usual standard of care with weights, length measurements, and monitoring intake to ensure adequate growth


Original Secondary Outcome: Same as current

Information By: Oregon Health and Science University

Dates:
Date Received: August 22, 2012
Date Started: June 2012
Date Completion:
Last Updated: October 13, 2015
Last Verified: October 2014