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Completed

NCT Number: NCT02143557

Dietary Treatment of Infants With Chylothorax

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.

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Key information

Conditions

Chylothorax Pleural Diseases Respiratory Tract Diseases

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fat-Modified Breast Milk

Other

MCT formula

Other

Primary outcomes

  1. Chyle Drainage from Chest Tubes

    Time frame: 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 outcomes

  1. Growth

    Time frame: 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.

Other outcomes

  1. Estimated Nutrient Intakes

    Time frame: 6 weeks of chylothorax treatment

    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).

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
First posted
May 21, 2014
Registry last updated
May 21, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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