Clinical trial NCT02143557: Dietary Treatment of Infants With Chylothorax
Official title: The Effectiveness of Low Fat Breast Milk for the Treatment of Chylothorax in Infants Following Cardiothoracic Surgery: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chylothorax
Keywords: breast milk
infants
chylothorax
cardiac surgery
modified breast milk
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Labatt Family Heart Centre
name: Trainee award through Ontario Student Opportunity Trust Fund - The Hospital for Sick Children Foundation Scholarship
First posted: 2014-05-21
Enrollment: 16
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Chylothorax occurs in \~3 to 5 % of infants undergoing cardiac surgery. Standard treatment requires discontinuation of breast milk feeding, due to the abundance of long chain triglycerides, and transition to a medium chain triglyceride (MCT) based formula. Objective: To determine the effectiveness of fat-modified breast milk (MBM) for the treatment of chylothorax compared with MCT-formula. Hypothesis: The investigators primary hypothesis was that infants fed MBM would have more chyle drainage in the first 5 days after diagnosis compared to infants fed an MCT based formula which is the current standard of care. Design: Infants with chylothorax were eligible. Treatment infants (n=8) received mother's own milk that had been modified by removing the fat layer via centrifugation and adding MCT and nutrients to provide 67 kcal/mL and 11 g/100 mL protein (MBM group). Control infants (n=8) received an MCT-formula (MCT group). The feeding intervention was a minimum of 6 weeks after chest tube removal per The Hospital for Sick Children standard chylothorax treatment protocol. Outcome measures collected included chyle drainage from chest tubes, weight, length and head circumference measurements and estimated energy and nutrient intake.


Eligibility criteria: Inclusion Criteria:

* Infants \< 12 months of age who were diagnosed with chylothorax.
* Infants included in the intervention group (MBM) needed to have received \>80% of their enteral feeds as breast milk prior to surgery.
* Infants included in the control group (MCT-formula) needed to have received \<80% of their enteral feeds as breast milk prior to surgery.

Exclusion Criteria:

* Subjects were excluded if their diagnosis made it unlikely that they would be able to follow the hospital's standard 6 week protocol for treatment of chylothorax
* Were receiving only parenteral nutrition at the time of diagnosis of chylothorax
* Primary caregiver of the baby did not have good comprehension of English.

Primary outcomes:
measure: Chyle Drainage from Chest Tubes
timeFrame: 6 weeks of chylothorax treatment
Secondary outcomes:
measure: Growth
timeFrame: 6 weeks of the chylothorax treatment
Other outcomes:
measure: Estimated Nutrient Intakes
timeFrame: 6 weeks of chylothorax treatment
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: Sarah Kocel, MSc RD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Hospital for Sick Children
name: Jennifer Russell, MD
role: PRINCIPAL_INVESTIGATOR
References: