Dietary Treatment of Infants With Chylothorax
Primary Purpose
Chylothorax
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Fat-Modified Breast Milk
MCT formula
Sponsored by
About this trial
This is an interventional supportive care trial for Chylothorax focused on measuring breast milk, infants, chylothorax, cardiac surgery, modified breast milk
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.
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Fat-Modified Breast Milk
MCT-formula group
Arm Description
Infants in this arm of the study were fed their own mother's breast milk where the fat layer was removed by centrifugation. Prior to feeding, extra energy and nutrients were added to the defatted breast milk.
Infants in this arm of the study were fed a MCT-containing medical food which is the current standard of care.
Outcomes
Primary Outcome Measures
Chyle Drainage from Chest Tubes
This outcome includes measurement of chyle drainage from chest tubes in the first 5 days after diagnosis of chylothorax and the number of days of chest tube drainage.
Secondary Outcome Measures
Growth
Infant weight, length and head circumference measurements were determined at study initiation and at the first post-discharge follow-up visit (within one-week of discharge) and again at the end of chylothorax treatment.
Full Information
NCT ID
NCT02143557
First Posted
May 12, 2014
Last Updated
May 17, 2014
Sponsor
The Hospital for Sick Children
Collaborators
Labatt Family Heart Centre, Trainee award through Ontario Student Opportunity Trust Fund - The Hospital for Sick Children Foundation Scholarship
1. Study Identification
Unique Protocol Identification Number
NCT02143557
Brief Title
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
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
Collaborators
Labatt Family Heart Centre, Trainee award through Ontario Student Opportunity Trust Fund - The Hospital for Sick Children Foundation Scholarship
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chylothorax
Keywords
breast milk, infants, chylothorax, cardiac surgery, modified breast milk
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fat-Modified Breast Milk
Arm Type
Experimental
Arm Description
Infants in this arm of the study were fed their own mother's breast milk where the fat layer was removed by centrifugation. Prior to feeding, extra energy and nutrients were added to the defatted breast milk.
Arm Title
MCT-formula group
Arm Type
Active Comparator
Arm Description
Infants in this arm of the study were fed a MCT-containing medical food which is the current standard of care.
Intervention Type
Other
Intervention Name(s)
Fat-Modified Breast Milk
Intervention Type
Other
Intervention Name(s)
MCT formula
Primary Outcome Measure Information:
Title
Chyle Drainage from Chest Tubes
Description
This outcome includes measurement of chyle drainage from chest tubes in the first 5 days after diagnosis of chylothorax and the number of days of chest tube drainage.
Time Frame
6 weeks of chylothorax treatment
Secondary Outcome Measure Information:
Title
Growth
Description
Infant weight, length and head circumference measurements were determined at study initiation and at the first post-discharge follow-up visit (within one-week of discharge) and again at the end of chylothorax treatment.
Time Frame
6 weeks of the chylothorax treatment
Other Pre-specified Outcome Measures:
Title
Estimated Nutrient Intakes
Description
Average daily energy, protein and other nutrient intakes were calculated using milk volumes consumed (recorded in the medical record [in-hospital] or 3 day consecutive food records [after discharge]), analyzed breast milk fat composition values, milk nutrient values from the literature, product monographs and Food Processor SQL Ed v. 10.2 (ESHA Research).
Time Frame
6 weeks of chylothorax treatment
10. Eligibility
Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah L O'Connor, PhD RD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sarah Kocel, MSc RD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jennifer Russell, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Dietary Treatment of Infants With Chylothorax
We'll reach out to this number within 24 hrs