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 ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Growth [ Time Frame: 6 weeks of the chylothorax treatment ]

Infant weight, length and head circumference measurements were determined at study initiation and at the first post-discharge follow-up visit (within one-week of discharge) and again at the end of 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