Chylothorax
Conditions
Keywords
breast milk, chylothorax, infants, cardiac surgery, modified fat breast milk
Brief summary
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.
Interventions
Sponsors
Labatt Family Heart Centre
Canadian Institutes of Health Research (CIHR)
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Growth - weight | Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient | z-score for weight-for-age |
| Growth - length | Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient | z-score for length-for-age |
| Growth - head circumference | Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient | z-score for head circumference-for-age |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Throughout chylothorax treatment (average 6 weeks); daily in hospital | ml/kg/day |
| Duration of chest tube drainage | Throughout chylothorax treatment (average 6 weeks); daily in hospital | measured in post-operative days |
| Feed volume intakes | Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient | — |
| Morbidities - reaccumulation of chylous fluid | Throughout chylothorax treatment (average 6 weeks) | — |
| Morbidities - prevalence of serious adverse events | Throughout chylothorax treatment (average 6 weeks) | — |
| Morbidities - hospital re-admission(s) | Throughout chylothorax treatment (average 6 weeks) | — |
| 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 | — |
Countries
Canada
Outcome results
None listed