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Dietary Treatment of Infants With Chylothorax

The Effectiveness of Low Fat Breast Milk for the Treatment of Chylothorax in Infants Following Cardiothoracic Surgery: A Pilot Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02143557
Enrollment
16
Registered
2014-05-21
Start date
2008-01-31
Completion date
Unknown
Last updated
2014-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chylothorax

Keywords

breast milk, infants, chylothorax, cardiac surgery, modified breast milk

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.

Interventions

OTHERFat-Modified Breast Milk
OTHERMCT formula

Sponsors

Labatt Family Heart Centre
CollaboratorOTHER
Trainee award through Ontario Student Opportunity Trust Fund - The Hospital for Sick Children Foundation Scholarship
CollaboratorUNKNOWN
The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
NON_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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Chyle Drainage from Chest Tubes6 weeks of chylothorax treatmentThis 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

MeasureTime frameDescription
Growth6 weeks of the chylothorax treatmentInfant 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.

Other

MeasureTime frameDescription
Estimated Nutrient Intakes6 weeks of chylothorax treatmentAverage 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).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026