Clinical trial NCT02577419: Optimizing Growth in Infants Receiving Modified Fat Breast Milk for the Treatment of Chylothorax
Official title: Optimizing Growth in Infants Receiving Modified Fat Breast Milk for the Treatment of Chylothorax Following Cardiothoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chylothorax
Keywords: breast milk
chylothorax
infants
cardiac surgery
modified fat breast milk
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Labatt Family Heart Centre
name: Canadian Institutes of Health Research (CIHR)
First posted: 2015-10-16
Enrollment: 24
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Growth - weight
timeFrame: Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient
measure: Growth - length
timeFrame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
measure: Growth - head circumference
timeFrame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Secondary outcomes:
measure: Feed volume intakes
timeFrame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
measure: Energy intakes
timeFrame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
measure: Protein intakes
timeFrame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
measure: Solid food intakes (type, grams at home measured using a scale (CS2000; Ohaus))
timeFrame: Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient
measure: Volume of chest tube drainage
timeFrame: Throughout chylothorax treatment (average 6 weeks); daily in hospital
measure: Duration of chest tube drainage
timeFrame: Throughout chylothorax treatment (average 6 weeks); daily in hospital
measure: Morbidities - hospital re-admission(s)
timeFrame: Throughout chylothorax treatment (average 6 weeks)
measure: Morbidities - reaccumulation of chylous fluid
timeFrame: Throughout chylothorax treatment (average 6 weeks)
measure: Morbidities - prevalence of serious adverse events
timeFrame: Throughout chylothorax treatment (average 6 weeks)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Deborah L O'Connor, PhD RD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Sara DiLauro, MSc(c) RD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Jennifer Russell, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.