Fortified Skimmed Mother's Milk in the Management of Chylothorax

Study Overview
=================
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.

Official Title
-----------------
A Comparison of the Effectiveness of Fortified Skimmed Mother's Milk Versus Specialized Formula in the Management of Chylous Effusion in Infants Following Cardiothoracic Surgery

Conditions
-----------------
Chylous Pleural Effusion Following Cardiothoracic Surgery

Intervention / Treatment
-----------------
* Other: Skimmed mother's milk
* Other: Specialized Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 12 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Specialized Formula<br>25 infants of mothers who do not have breast milk or do not want to use the skimming technique. These infants will receive our standard of care - specialized formula for the treatment of chylothorax | Other: Specialized Formula<br>* Infants will receive our standard of care - specialized formula<br>|
| Experimental: Skimmed mother's milk<br>25 infants of mothers who have breast milk and who also want to learn the skimming technique will be taught the technique. The infants will then receive the skimmed breast milk for the treatment of chylothorax | Other: Skimmed mother's milk<br>* 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<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the time to resolution of chylothorax of infants receiving skimmed mother's milk versus specialized formula. | 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 | up to 2 months from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the recurrence rate of chylous effusion in infants receiving skimmed mother's milk versus specialized formula. | 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. | up to 4 months after hospital discharge | 
| To evaluate the technique of skimming and fortifying breast milk | 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. | the first 30 days after enrollment | 
| To compare feeding tolerance, growth, and nutrition in infants who receive fortified skimmed mother's milk versus specialized formula | 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 | 2 months |