Dietary Treatment of Infants With Chylothorax

Chylothorax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02143557
• Other study ID #: 1000011037
• Secondary ID: 1000037303
• Status: Completed
• Phase: N/A
• First received: May 12, 2014
• Last updated: May 17, 2014
• Start date: January 2008

Study information

• Verified date: May 2014
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Months

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chylothorax

Intervention

Other:
• Fat-Modified Breast Milk

• MCT formula

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Labatt Family Heart Centre, Trainee award through Ontario Student Opportunity Trust Fund - The Hospital for Sick Children Foundation Scholarship

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Estimated Nutrient Intakes	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).	6 weeks of chylothorax treatment	No
Primary	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.	6 weeks of chylothorax treatment	Yes
Secondary	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.	6 weeks of the chylothorax treatment	Yes