Oregon Health and Science University - Doernbecher Children's Hospital
Portland, Oregon, 97239, United States
Completed
NCT Number: NCT01673165
Fortified Skimmed Mother's Milk in the Management of Chylothorax
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.
Completed
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Notify MeKey information
Age range
1 day–12 month
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Skimmed mother's milk
OtherFortified 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
Specialized Formula
OtherInfants will receive our standard of care - specialized formula
Primary outcomes
-
To evaluate the time to resolution of chylothorax of infants receiving skimmed mother's milk versus specialized formula.
Time frame: 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 outcomes
-
To evaluate the recurrence rate of chylous effusion in infants receiving skimmed mother's milk versus specialized formula.
Time frame: 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
Time frame: 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
Time frame: 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
Sponsors and collaborators
Lead sponsor
Oregon Health and Science University
Other
Collaborators
- The Gerber Foundation
Registry information
Official study 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
Important dates
- Study start
- 2012
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Aug 27, 2012
- Registry last updated
- Oct 14, 2015
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.