Optimizing Growth in Infants Receiving Modified Fat Breast Milk for the Treatment of Chylothorax

Study Overview
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Brief Summary
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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.

Official Title
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Optimizing Growth in Infants Receiving Modified Fat Breast Milk for the Treatment of Chylothorax Following Cardiothoracic Surgery

Conditions
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Chylothorax

Intervention / Treatment
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* Other: Target Fortification
* Other: Higher Initial Concentration
* Other: Portagen Formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: confirmed diagnosis of chylothorax following cardiothoracic surgery previously receiving a minimum of 50% of feeds from breast milk 3 days prior to surgical procedure parents/caregivers would like to continue to provide breast milk during chylothorax treatment Exclusion Criteria: diagnoses of chylothorax classified as either congenital, obstructive, or traumatic not following cardiothoracic surgery patient has a chromosomal anomaly that affects growth (i.e. Trisomy 21, Trisomy 18 etc.) patient receiving less than 50% of feeds from breast milk (or mother does not have intention to provide breast milk) neither parent/caregiver/family member able to communicate effectively in English

Ages Eligible for Study
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Maximum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Target Fortification<br> | Other: Target Fortification<br> <br> |
| Experimental: Higher Initial Concentration<br> | Other: Higher Initial Concentration<br> <br> |
| Active Comparator: Portagen Growth Reference<br> | Other: Portagen Formula<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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) | 

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