Dietary Treatment of Infants With Chylothorax

Study Overview
=================
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.

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

Conditions
-----------------
Chylothorax

Intervention / Treatment
-----------------
* Other: Fat-Modified Breast Milk
* Other: MCT formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fat-Modified Breast Milk<br>Infants in this arm of the study were fed their own mother's breast milk where the fat layer was removed by centrifugation. Prior to feeding, extra energy and nutrients were added to the defatted breast milk. | Other: Fat-Modified Breast Milk<br> <br> |
| Active Comparator: MCT-formula group<br>Infants in this arm of the study were fed a MCT-containing medical food which is the current standard of care. | Other: MCT formula<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chyle Drainage from Chest Tubes | 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. | 6 weeks of chylothorax treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth | 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. | 6 weeks of the chylothorax treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast milk, infants, chylothorax, cardiac surgery, modified breast milk