Dietary Treatment of Infants With Chylothorax

The Hospital for Sick Children

Status: Completed

Conditions: Chylothorax

Treatments: Other: Fat-Modified Breast Milk; Other: MCT formula

Study type: Interventional

Funder types: Other

Identifiers

NCT02143557

1000037303 (Other Identifier)

1000011037

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: Under 12 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Fat-Modified Breast Milk

Experimental group

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.

Treatment:

Other: Fat-Modified Breast Milk

MCT-formula group

Active Comparator group

Description:

Infants in this arm of the study were fed a MCT-containing medical food which is the current standard of care.

Treatment:

Other: MCT formula