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Fortified Skimmed Mother's Milk in the Management of Chylothorax

Primary Purpose

Chylous Pleural Effusion Following Cardiothoracic Surgery

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Skimmed mother's milk
Specialized Formula
Sponsored by
Oregon Health and Science University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chylous Pleural Effusion Following Cardiothoracic Surgery

Eligibility Criteria

1 Day - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Oregon Health and Science University - Doernbecher Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Specialized Formula

Skimmed mother's milk

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
August 22, 2012
Last Updated
October 13, 2015
Sponsor
Oregon Health and Science University
Collaborators
The Gerber Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01673165
Brief Title
Fortified Skimmed Mother's Milk in the Management of Chylothorax
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
The Gerber Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chylous Pleural Effusion Following Cardiothoracic Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Specialized Formula
Arm Type
Active Comparator
Arm Description
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
Arm Title
Skimmed mother's milk
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Skimmed mother's milk
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Specialized Formula
Intervention Description
Infants will receive our standard of care - specialized formula
Primary Outcome Measure Information:
Title
To evaluate the time to resolution of chylothorax of infants receiving skimmed mother's milk versus specialized formula.
Description
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
Time Frame
up to 2 months from enrollment
Secondary Outcome Measure Information:
Title
To evaluate the recurrence rate of chylous effusion in infants receiving skimmed mother's milk versus specialized formula.
Description
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.
Time Frame
up to 4 months after hospital discharge
Title
To evaluate the technique of skimming and fortifying breast milk
Description
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.
Time Frame
the first 30 days after enrollment
Title
To compare feeding tolerance, growth, and nutrition in infants who receive fortified skimmed mother's milk versus specialized formula
Description
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
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindi Farnstrom, MN, CPNP
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health and Science University - Doernbecher Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
2061800
Citation
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Chan EH, Russell JL, Williams WG, Van Arsdell GS, Coles JG, McCrindle BW. Postoperative chylothorax after cardiothoracic surgery in children. Ann Thorac Surg. 2005 Nov;80(5):1864-70. doi: 10.1016/j.athoracsur.2005.04.048.
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PubMed Identifier
10802499
Citation
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Fortified Skimmed Mother's Milk in the Management of Chylothorax

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