Chylous Pleural Effusion Following Cardiothoracic Surgery
Conditions
Brief summary
The purpose of this study is to determine if the use of fortified skimmed mother's milk is a safe alternative to specialized formula in the treatment of chylothorax following cardiothoracic surgery.
Detailed description
A chylothorax is a collection of fluid around the lungs that can occur after cardiac surgery. The fluid contains chyle, a milky fluid consisting of fat droplets. The standard treatment is to feed an infant with a specialized low fat formula for up to 6 weeks until the chest has time to heal. This formula is generally not well tolerated and mother's of our patients have expressed a desire to continue using breast milk. A few case reports have been published, but there have not been any studies to date looking at this. Data will be collected to include information about nutrition, weight gain, teaching needs, surgical, hospital, and discharge information.
Interventions
OTHERSkimmed mother's milk
Fortified skimmed mother's milk will be given to the skimmed mother's milk group. The fortifier is a standard fortifier we use in our population
OTHERSpecialized Formula
Infants will receive our standard of care - specialized formula
Sponsors
The Gerber Foundation
Oregon Health and Science University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Days to 12 Months
Healthy volunteers
No
Inclusion criteria
* Infant birth to 12 months of age * Undergo cardiothoracic surgery * Develop a chylous effusion * Be a breastfed or formula fed infant
Exclusion criteria
* Infant over 12 months of age * Infant in state custody (foster care) * Infant with milk protein allergy * Infant born with congenital chylothorax * Infant who develops chylothorax from other surgeries (non-cardiac
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the time to resolution of chylothorax of infants receiving skimmed mother's milk versus specialized formula. | up to 2 months from enrollment | Fluid around the lungs is assessed by chest radiographs (x-rays) as per our usual standard of care. Cloudy fluid will be sent for analysis (chylomicrons, cell count, lymphocytes, and triglycerides) to confirm the diagnosis. The date of diagnosis, the date of chest tube removal, and the date of resolution of effusion by chest xrays |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the recurrence rate of chylous effusion in infants receiving skimmed mother's milk versus specialized formula. | up to 4 months after hospital discharge | All patients receive a standard chest x-ray prior to discharge from the hospital and again in two weeks at their follow up appointment. If symptoms of respiratory difficulty occur prior to or following this time, additional chest x-rays may be obtained based on exam findings and clinical judgment. The date of recurrence of effusion will be recorded as will the date of chest tube insertion if required. |
| To evaluate the technique of skimming and fortifying breast milk | the first 30 days after enrollment | The skimming technique will be taught to participating mothers and nurses caring for their infants. A sample of the skim milk will be analyzed by a creamatocrit for fat and caloric content. |
| To compare feeding tolerance, growth, and nutrition in infants who receive fortified skimmed mother's milk versus specialized formula | 2 months | Feeding symptoms observed by clinical staff and parents will be recorded. Parents will complete a questionnaire and score symptoms based on severity. Infants will be monitored as per our usual standard of care with weights, length measurements, and monitoring intake to ensure adequate growth |
Countries
United States
Outcome results
None listed