Dietary Treatment of Infants With Chylothorax

Not Applicable

Completed

• Conditions: Chylothorax
• Interventions: Other: Fat-Modified Breast Milk; Other: MCT formula

• Registration Number: NCT02143557
• Lead Sponsor: The Hospital for Sick Children

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Primary Completion: 2010-02
• Status Verified: 2014-05
• Study First Submitted: 2014-05-12
• Study First Submitted QC: 2014-05-17
• Last Update Submitted: 2014-05-17
• Study First Posted: 2014-05-21
• Last Update Posted: 2014-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fat-Modified Breast Milk	Fat-Modified Breast Milk	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.
MCT-formula group	MCT formula	Infants in this arm of the study were fed a MCT-containing medical food which is the current standard of care.

Primary Outcome Measures

Name	Time	Method
Chyle Drainage from Chest Tubes	6 weeks of chylothorax treatment	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

Name	Time	Method
Growth	6 weeks of the chylothorax treatment	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.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada