Fortified Skimmed Mother's Milk in the Management of Chylothorax

This study is currently recruiting participants.
Verified August 2012 by Oregon Health and Science University
Sponsor:
Collaborator:
The Gerber Foundation
Information provided by (Responsible Party):
Cindi Farnstrom, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01673165
First received: August 22, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 50
Study Start Date: June 2012
Estimated Study Completion Date: June 2015
Estimated 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

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01673165

Locations
United States, Oregon
Oregon Health and Science University - Doernbecher Children's Hospital Recruiting
Portland, Oregon, United States, 97239
Contact: Cindi L Farnstrom, MN CPNP    503-494-8197    farnstro@ohsu.edu   
Contact: Alisa Tortorich, RD    503-494-9000    deweeswa@ohsu.edu   
Principal Investigator: Cindi Farnstrom, MN, CPNP         
Sub-Investigator: Alisa Tortorich, RD         
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:

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
Study First Received: August 22, 2012
Last Updated: August 22, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014