Clinical Trials Directory

Trials / Completed

CompletedNCT02143557

Dietary Treatment of Infants With Chylothorax

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
16 (actual)
Sponsor
The Hospital for Sick Children · Academic / Other
Sex
All
Age
12 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERFat-Modified Breast Milk
OTHERMCT formula

Timeline

Start date
2008-01-01
Primary completion
2010-02-01
First posted
2014-05-21
Last updated
2014-05-21

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02143557. Inclusion in this directory is not an endorsement.