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| Name | Class |
|---|---|
| Labatt Family Heart Centre | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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Breast milk is the reference normative standard for infant feeding. When an infant is diagnosed with chylothorax, provision of breast milk must be temporarily discontinued due to the presence of long chain triglycerides (LCT) that contribute to persistent chylous drainage. In its place, the infant is prescribed a therapeutic formula high in medium chain triglycerides (MCT) as treatment for chylothorax. Families and health care providers are interested in using breast milk, in a modified fat form, as treatment for chylothorax instead. This study will assess growth in infants receiving one of two nutrient enriched modified fat breast milk (MFBM) treatments for chylothorax. If either of the proposed nutrient enrichment methods support growth, MFBM will become a standard chylothorax treatment option for infants at SickKids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Target Fortification | Experimental |
| |
| Higher Initial Concentration | Experimental |
| |
| Portagen Growth Reference | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Target Fortification | Other |
| ||
| Higher Initial Concentration |
| Measure | Description | Time Frame |
|---|---|---|
| Growth - weight | z-score for weight-for-age | Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient |
| Growth - length | z-score for length-for-age | Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient |
| Growth - head circumference | z-score for head circumference-for-age | Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient |
| Measure | Description | Time Frame |
|---|---|---|
| Feed volume intakes | Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient | |
| Energy intakes | Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient |
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deborah L O'Connor, PhD RD | The Hospital for Sick Children | Principal Investigator |
| Sara DiLauro, MSc(c) 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25560680 | Background | Kocel SL, Russell J, O'Connor DL. Fat-Modified Breast Milk Resolves Chylous Pleural Effusion in Infants With Postsurgical Chylothorax but Is Associated With Slow Growth. JPEN J Parenter Enteral Nutr. 2016 May;40(4):543-51. doi: 10.1177/0148607114566464. Epub 2015 Jan 5. | |
| 32690156 | Background | DiLauro S, Russell J, McCrindle BW, Tomlinson C, Unger S, O'Connor DL. Growth of cardiac infants with post-surgical chylothorax can be supported using modified fat breast milk with proactive nutrient-enrichment and advancement feeding protocols; an open-label trial. Clin Nutr ESPEN. 2020 Aug;38:19-27. doi: 10.1016/j.clnesp.2020.05.001. Epub 2020 May 23. |
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| ID | Term |
|---|---|
| D002916 | Chylothorax |
| ID | Term |
|---|---|
| D010995 | Pleural Diseases |
| D012140 | Respiratory Tract Diseases |
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| Other |
|
| Portagen Formula | Other |
|
| Protein intakes | Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient |
| Solid food intakes (type, grams at home measured using a scale (CS2000; Ohaus)) | Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient |
| Volume of chest tube drainage | ml/kg/day | Throughout chylothorax treatment (average 6 weeks); daily in hospital |
| Duration of chest tube drainage | measured in post-operative days | Throughout chylothorax treatment (average 6 weeks); daily in hospital |
| Morbidities - hospital re-admission(s) | Throughout chylothorax treatment (average 6 weeks) |
| Morbidities - reaccumulation of chylous fluid | Throughout chylothorax treatment (average 6 weeks) |
| Morbidities - prevalence of serious adverse events | Throughout chylothorax treatment (average 6 weeks) |