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Fortified Skimmed Mother's Milk in the Management of Chylothorax

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01673165
First Posted: August 27, 2012
Last Update Posted: October 14, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Gerber Foundation
Information provided by (Responsible Party):
Cindi Farnstrom, Oregon Health and Science University
  Purpose
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.

Condition Intervention
Chylous Pleural Effusion Following Cardiothoracic Surgery Other: Skimmed mother's milk Other: Specialized Formula

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

Further study details as provided by Cindi Farnstrom, Oregon Health and Science University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 17
Study Start Date: June 2012
Study Completion Date: September 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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
Other: Specialized Formula
Infants will receive our standard of care - specialized formula
Experimental: 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
Other: Skimmed 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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01673165


Locations
United States, Oregon
Oregon Health and Science University - Doernbecher Children's Hospital
Portland, Oregon, United States, 97239
Sponsors and Collaborators
Oregon Health and Science University
The Gerber Foundation
Investigators
Principal Investigator: Cindi Farnstrom, MN, CPNP Oregon Health and Science University
  More Information

Publications:
Lessen R. Use of skim breast milk for an infant with chylothorax. ICAN: Infant, Child, & Adolescent Nutrition. 2009; 1(6):303-310.

Responsible Party: Cindi Farnstrom, Certified Pediatric Nurse Practitioner, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01673165     History of Changes
Other Study ID Numbers: Gerber7747
First Submitted: August 22, 2012
First Posted: August 27, 2012
Last Update Posted: October 14, 2015
Last Verified: October 2014

Additional relevant MeSH terms:
Pleural Effusion
Chylothorax
Pleural Diseases
Respiratory Tract Diseases