Dietary Treatment of Infants With Chylothorax

NCT02143557 | Completed

• 2 other identifiers: 10000110371000037303
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chylothorax

Keywords

breast milk; infants; chylothorax; cardiac surgery; modified breast milk

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Growth

  6 weeks of the chylothorax treatment

Other Outcomes (1)

• Estimated Nutrient Intakes

  6 weeks of chylothorax treatment

Study Arms (2)

Fat-Modified Breast Milk

EXPERIMENTAL

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.

Other: Fat-Modified Breast Milk

MCT-formula group

ACTIVE COMPARATOR

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

Other: MCT formula

Interventions

Fat-Modified Breast Milk OTHER

Fat-Modified Breast Milk

MCT formula OTHER

MCT-formula group

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Labatt Family Heart Centre: collaborator
• Trainee award through Ontario Student Opportunity Trust Fund - The Hospital for Sick Children Foundation Scholarship: collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Chylothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Deborah L O'Connor, PhD RD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Sarah Kocel, MSc RD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Jennifer Russell, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Scientist

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 21, 2014
• Study Start: January 1, 2008
• Primary Completion: February 1, 2010
• Last Updated: May 21, 2014

Record last verified: 2014-05

Locations

CA (1)