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| ID | Type | Description | Link |
|---|---|---|---|
| 1000037303 | Other Identifier | The Hospital for Sick Children Research Ethics Board |
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| Name | Class |
|---|---|
| Labatt Family Heart Centre | OTHER |
| Trainee award through Ontario Student Opportunity Trust Fund - The Hospital for Sick Children Foundation Scholarship | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fat-Modified Breast Milk | Experimental | 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. |
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| MCT-formula group | Active Comparator | Infants in this arm of the study were fed a MCT-containing medical food which is the current standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fat-Modified Breast Milk | Other |
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| MCT formula |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Nutrient Intakes | Average daily energy, protein and other nutrient intakes were calculated using milk volumes consumed (recorded in the medical record [in-hospital] or 3 day consecutive food records [after discharge]), analyzed breast milk fat composition values, milk nutrient values from the literature, product monographs and Food Processor SQL Ed v. 10.2 (ESHA Research). | 6 weeks of chylothorax treatment |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah L O'Connor, PhD RD | The Hospital for Sick Children | Principal Investigator |
| Sarah Kocel, MSc RD | The Hospital for Sick Children | Principal Investigator |
| Jennifer Russell, MD | The Hospital for Sick Children | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
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| ID | Term |
|---|---|
| D002916 | Chylothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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