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Dietary Treatment of Infants With Chylothorax

NCT02143557 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2014-05-21

No results posted yet for this study

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

Interventions

OTHER

Fat-Modified Breast Milk

OTHER

MCT formula

Sponsors & Collaborators

  • Labatt Family Heart Centre

    collaborator OTHER

  • Trainee award through Ontario Student Opportunity Trust Fund - The Hospital for Sick Children Foundation Scholarship

    collaborator UNKNOWN

  • The Hospital for Sick Children

    lead OTHER

Principal Investigators

  • Deborah L O'Connor, PhD RD · The Hospital for Sick Children

  • Sarah Kocel, MSc RD · The Hospital for Sick Children

  • Jennifer Russell, MD · The Hospital for Sick Children

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-02-28

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02143557 on ClinicalTrials.gov