Dietary Treatment of Infants With Chylothorax

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Brief Summary

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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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Detailed Description

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Conditions

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Chylothorax

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Fat-Modified Breast Milk

Intervention Type OTHER

MCT-formula group

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

Group Type ACTIVE_COMPARATOR

MCT formula

Intervention Type OTHER

Interventions

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Fat-Modified Breast Milk

Intervention Type OTHER

MCT formula

Intervention Type OTHER

Eligibility Criteria

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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.

Maximum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No