Fortified Skimmed Mother's Milk in the Management of Chylothorax

Not Applicable

Completed

• Conditions: Chylous Pleural Effusion Following Cardiothoracic Surgery
• Interventions: Other: Skimmed mother's milk; Other: Specialized Formula

• Registration Number: NCT01673165
• Lead Sponsor: Oregon Health and Science University

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-08-22
• Study First Submitted QC: 2012-08-22
• Study First Posted: 2012-08-27
• Status Verified: 2014-10
• Primary Completion: 2015-06
• Study Completion: 2015-09
• Last Update Submitted: 2015-10-13
• Last Update Posted: 2015-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Skimmed mother's milk	Skimmed mother's milk	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
Specialized Formula	Specialized Formula	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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

Trial Locations

Locations (1)

Oregon Health and Science University - Doernbecher Children's Hospital; 🇺🇸 Portland, Oregon, United States