Clinical Trial: Dietary Treatment of Infants With Chylothorax
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: The Effectiveness of Low Fat Breast Milk for the Treatment of Chylothorax in Infants Following Cardiothoracic Surgery: A Pilot Study
Brief Summary: 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.
Detailed Summary:
Sponsor: The Hospital for Sick Children
Current Primary Outcome: Chyle Drainage from Chest Tubes [ Time Frame: 6 weeks of chylothorax treatment ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Growth [ Time Frame: 6 weeks of the chylothorax treatment ]
Original Secondary Outcome: Same as current
Information By: The Hospital for Sick Children
Dates:
Date Received: May 12, 2014
Date Started: January 2008
Date Completion:
Last Updated: May 17, 2014
Last Verified: May 2014