Optimizing Growth in Infants Receiving Modified Fat Breast Milk for the Treatment of Chylothorax (NCT02577419) | Clinical Trial Compass
CompletedNot Applicable
Optimizing Growth in Infants Receiving Modified Fat Breast Milk for the Treatment of Chylothorax
Canada24 participantsStarted 2015-10
Plain-language 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.
Who can participate
Age range
12 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Growth - weight
Timeframe: Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient
2
Growth - length
Timeframe: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
3
Growth - head circumference
Timeframe: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient