<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01673165</url>
  </required_header>
  <id_info>
    <org_study_id>Gerber7747</org_study_id>
    <nct_id>NCT01673165</nct_id>
  </id_info>
  <brief_title>Fortified Skimmed Mother's Milk in the Management of Chylothorax</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Gerber Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the use of fortified skimmed mother's milk is a&#xD;
      safe alternative to specialized formula in the treatment of chylothorax following&#xD;
      cardiothoracic surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A chylothorax is a collection of fluid around the lungs that can occur after cardiac surgery.&#xD;
      The fluid contains chyle, a milky fluid consisting of fat droplets. The standard treatment is&#xD;
      to feed an infant with a specialized low fat formula for up to 6 weeks until the chest has&#xD;
      time to heal. This formula is generally not well tolerated and mother's of our patients have&#xD;
      expressed a desire to continue using breast milk. A few case reports have been published, but&#xD;
      there have not been any studies to date looking at this. Data will be collected to include&#xD;
      information about nutrition, weight gain, teaching needs, surgical, hospital, and discharge&#xD;
      information.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate the time to resolution of chylothorax of infants receiving skimmed mother's milk versus specialized formula.</measure>
    <time_frame>up to 2 months from enrollment</time_frame>
    <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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate the recurrence rate of chylous effusion in infants receiving skimmed mother's milk versus specialized formula.</measure>
    <time_frame>up to 4 months after hospital discharge</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the technique of skimming and fortifying breast milk</measure>
    <time_frame>the first 30 days after enrollment</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare feeding tolerance, growth, and nutrition in infants who receive fortified skimmed mother's milk versus specialized formula</measure>
    <time_frame>2 months</time_frame>
    <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</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Chylous Pleural Effusion Following Cardiothoracic Surgery</condition>
  <arm_group>
    <arm_group_label>Specialized Formula</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Skimmed mother's milk</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Skimmed mother's milk</intervention_name>
    <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</description>
    <arm_group_label>Skimmed mother's milk</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Specialized Formula</intervention_name>
    <description>Infants will receive our standard of care - specialized formula</description>
    <arm_group_label>Specialized Formula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infant birth to 12 months of age&#xD;
&#xD;
          -  Undergo cardiothoracic surgery&#xD;
&#xD;
          -  Develop a chylous effusion&#xD;
&#xD;
          -  Be a breastfed or formula fed infant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infant over 12 months of age&#xD;
&#xD;
          -  Infant in state custody (foster care)&#xD;
&#xD;
          -  Infant with milk protein allergy&#xD;
&#xD;
          -  Infant born with congenital chylothorax&#xD;
&#xD;
          -  Infant who develops chylothorax from other surgeries (non-cardiac&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cindi Farnstrom, MN, CPNP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oregon Health and Science University - Doernbecher Children's Hospital</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Le Coultre C, Oberhansli I, Mossaz A, Bugmann P, Faidutti B, Belli DC. Postoperative chylothorax in children: differences between vascular and traumatic origin. J Pediatr Surg. 1991 May;26(5):519-23. doi: 10.1016/0022-3468(91)90696-q.</citation>
    <PMID>2061800</PMID>
  </reference>
  <reference>
    <citation>Milonakis M, Chatzis AC, Giannopoulos NM, Contrafouris C, Bobos D, Kirvassilis GV, Sarris GE. Etiology and management of chylothorax following pediatric heart surgery. J Card Surg. 2009 Jul-Aug;24(4):369-73. doi: 10.1111/j.1540-8191.2008.00781.x.</citation>
    <PMID>19583606</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16242470</PMID>
  </reference>
  <reference>
    <citation>Beghetti M, La Scala G, Belli D, Bugmann P, Kalangos A, Le Coultre C. Etiology and management of pediatric chylothorax. J Pediatr. 2000 May;136(5):653-8. doi: 10.1067/mpd.2000.104287.</citation>
    <PMID>10802499</PMID>
  </reference>
  <reference>
    <citation>Bond SJ, Guzzetta PC, Snyder ML, Randolph JG. Management of pediatric postoperative chylothorax. Ann Thorac Surg. 1993 Sep;56(3):469-72; discussion 472-3. doi: 10.1016/0003-4975(93)90881-h.</citation>
    <PMID>8379718</PMID>
  </reference>
  <reference>
    <citation>Suddaby EC, Schiller S. Management of chylothorax in children. Pediatr Nurs. 2004 Jul-Aug;30(4):290-5.</citation>
    <PMID>15511045</PMID>
  </reference>
  <reference>
    <citation>Allen EM, van Heeckeren DW, Spector ML, Blumer JL. Management of nutritional and infectious complications of postoperative chylothorax in children. J Pediatr Surg. 1991 Oct;26(10):1169-74. doi: 10.1016/0022-3468(91)90325-n.</citation>
    <PMID>1779326</PMID>
  </reference>
  <reference>
    <citation>Lessen R. Use of skim breast milk for an infant with chylothorax. ICAN: Infant, Child, &amp; Adolescent Nutrition. 2009; 1(6):303-310.</citation>
  </reference>
  <reference>
    <citation>Chan GM, Lechtenberg E. The use of fat-free human milk in infants with chylous pleural effusion. J Perinatol. 2007 Jul;27(7):434-6. doi: 10.1038/sj.jp.7211768. Epub 2007 Jun 7.</citation>
    <PMID>17554391</PMID>
  </reference>
  <reference>
    <citation>Staats BA, Ellefson RD, Budahn LL, Dines DE, Prakash UB, Offord K. The lipoprotein profile of chylous and nonchylous pleural effusions. Mayo Clin Proc. 1980 Nov;55(11):700-4.</citation>
    <PMID>7442324</PMID>
  </reference>
  <reference>
    <citation>Cormack BE, Wilson NJ, Finucane K, West TM. Use of Monogen for pediatric postoperative chylothorax. Ann Thorac Surg. 2004 Jan;77(1):301-5. doi: 10.1016/s0003-4975(03)01189-5.</citation>
    <PMID>14726083</PMID>
  </reference>
  <reference>
    <citation>Orange JS, Geha RS, Bonilla FA. Acute chylothorax in children: selective retention of memory T cells and natural killer cells. J Pediatr. 2003 Aug;143(2):243-9. doi: 10.1067/S0022-3476(03)00305-6.</citation>
    <PMID>12970641</PMID>
  </reference>
  <reference>
    <citation>Sheeran T, Marvin RS, Pianta RC. Mothers' resolution of their child's diagnosis and self-reported measures of parenting stress, marital relations, and social support. J Pediatr Psychol. 1997 Apr;22(2):197-212. doi: 10.1093/jpepsy/22.2.197.</citation>
    <PMID>9114643</PMID>
  </reference>
  <reference>
    <citation>Wang CD, Chu PS, Mellen BG, Shenai JP. Creamatocrit and the nutrient composition of human milk. J Perinatol. 1999 Jul-Aug;19(5):343-6. doi: 10.1038/sj.jp.7200204.</citation>
    <PMID>10685254</PMID>
  </reference>
  <reference>
    <citation>Chatterjee R, Chatterjee S, Datta T, Roy B, Marimuthu P. Longitudinal study of human milk creamatocrit and weight gain in exclusively breastfed infants. Indian Pediatr. 1997 Oct;34(10):901-4.</citation>
    <PMID>9567552</PMID>
  </reference>
  <reference>
    <citation>Lucas A, Gibbs JA, Lyster RL, Baum JD. Creamatocrit: simple clinical technique for estimating fat concentration and energy value of human milk. Br Med J. 1978 Apr 22;1(6119):1018-20. doi: 10.1136/bmj.1.6119.1018.</citation>
    <PMID>638579</PMID>
  </reference>
  <reference>
    <citation>Buttiker V, Fanconi S, Burger R. Chylothorax in children: guidelines for diagnosis and management. Chest. 1999 Sep;116(3):682-7. doi: 10.1378/chest.116.3.682.</citation>
    <PMID>10492271</PMID>
  </reference>
  <reference>
    <citation>Lewis CC, Scott DE, Pantell RH, Wolf MH. Parent satisfaction with children's medical care. Development, field test, and validation of a questionnaire. Med Care. 1986 Mar;24(3):209-15. doi: 10.1097/00005650-198603000-00003.</citation>
    <PMID>3951263</PMID>
  </reference>
  <reference>
    <citation>Berseth CL, Mitmesser SH, Ziegler EE, Marunycz JD, Vanderhoof J. Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants. Nutr J. 2009 Jun 19;8:27. doi: 10.1186/1475-2891-8-27.</citation>
    <PMID>19545360</PMID>
  </reference>
  <verification_date>October 2014</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2012</study_first_posted>
  <last_update_submitted>October 13, 2015</last_update_submitted>
  <last_update_submitted_qc>October 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Cindi Farnstrom</investigator_full_name>
    <investigator_title>Certified Pediatric Nurse Practitioner</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pleural Effusion</mesh_term>
    <mesh_term>Chylothorax</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01673165
org study id: Gerber7747
nct id: NCT01673165
lead sponsor: 
collaborator: 
has dmc: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 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
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
measure: 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
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.
measure: To evaluate the technique of skimming and fortifying breast milk
time frame: the first 30 days after enrollment
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.
measure: To compare feeding tolerance, growth, and nutrition in infants who receive fortified skimmed mother's milk versus specialized formula
time frame: 2 months
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
arm group label: Specialized Formula
arm group type: Active Comparator
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 group label: Skimmed mother's milk
arm group type: Experimental
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: Skimmed mother's milk
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
arm group label: Skimmed mother's milk
intervention type: Other
intervention name: Specialized Formula
description: Infants will receive our standard of care - specialized formula
arm group label: Specialized Formula
criteria: 
gender: All
minimum age: 1 Day
maximum age: 12 Months
healthy volunteers: No
last name: Cindi Farnstrom, MN, CPNP
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
citation: Le Coultre C, Oberhansli I, Mossaz A, Bugmann P, Faidutti B, Belli DC. Postoperative chylothorax in children: differences between vascular and traumatic origin. J Pediatr Surg. 1991 May;26(5):519-23. doi: 10.1016/0022-3468(91)90696-q.
PMID: 2061800
citation: Milonakis M, Chatzis AC, Giannopoulos NM, Contrafouris C, Bobos D, Kirvassilis GV, Sarris GE. Etiology and management of chylothorax following pediatric heart surgery. J Card Surg. 2009 Jul-Aug;24(4):369-73. doi: 10.1111/j.1540-8191.2008.00781.x.
PMID: 19583606
citation: 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.
PMID: 16242470
citation: Beghetti M, La Scala G, Belli D, Bugmann P, Kalangos A, Le Coultre C. Etiology and management of pediatric chylothorax. J Pediatr. 2000 May;136(5):653-8. doi: 10.1067/mpd.2000.104287.
PMID: 10802499
citation: Bond SJ, Guzzetta PC, Snyder ML, Randolph JG. Management of pediatric postoperative chylothorax. Ann Thorac Surg. 1993 Sep;56(3):469-72; discussion 472-3. doi: 10.1016/0003-4975(93)90881-h.
PMID: 8379718
citation: Suddaby EC, Schiller S. Management of chylothorax in children. Pediatr Nurs. 2004 Jul-Aug;30(4):290-5.
PMID: 15511045
citation: Allen EM, van Heeckeren DW, Spector ML, Blumer JL. Management of nutritional and infectious complications of postoperative chylothorax in children. J Pediatr Surg. 1991 Oct;26(10):1169-74. doi: 10.1016/0022-3468(91)90325-n.
PMID: 1779326
citation: Lessen R. Use of skim breast milk for an infant with chylothorax. ICAN: Infant, Child, & Adolescent Nutrition. 2009; 1(6):303-310.
citation: Chan GM, Lechtenberg E. The use of fat-free human milk in infants with chylous pleural effusion. J Perinatol. 2007 Jul;27(7):434-6. doi: 10.1038/sj.jp.7211768. Epub 2007 Jun 7.
PMID: 17554391
citation: Staats BA, Ellefson RD, Budahn LL, Dines DE, Prakash UB, Offord K. The lipoprotein profile of chylous and nonchylous pleural effusions. Mayo Clin Proc. 1980 Nov;55(11):700-4.
PMID: 7442324
citation: Cormack BE, Wilson NJ, Finucane K, West TM. Use of Monogen for pediatric postoperative chylothorax. Ann Thorac Surg. 2004 Jan;77(1):301-5. doi: 10.1016/s0003-4975(03)01189-5.
PMID: 14726083
citation: Orange JS, Geha RS, Bonilla FA. Acute chylothorax in children: selective retention of memory T cells and natural killer cells. J Pediatr. 2003 Aug;143(2):243-9. doi: 10.1067/S0022-3476(03)00305-6.
PMID: 12970641
citation: Sheeran T, Marvin RS, Pianta RC. Mothers' resolution of their child's diagnosis and self-reported measures of parenting stress, marital relations, and social support. J Pediatr Psychol. 1997 Apr;22(2):197-212. doi: 10.1093/jpepsy/22.2.197.
PMID: 9114643
citation: Wang CD, Chu PS, Mellen BG, Shenai JP. Creamatocrit and the nutrient composition of human milk. J Perinatol. 1999 Jul-Aug;19(5):343-6. doi: 10.1038/sj.jp.7200204.
PMID: 10685254
citation: Chatterjee R, Chatterjee S, Datta T, Roy B, Marimuthu P. Longitudinal study of human milk creamatocrit and weight gain in exclusively breastfed infants. Indian Pediatr. 1997 Oct;34(10):901-4.
PMID: 9567552
citation: Lucas A, Gibbs JA, Lyster RL, Baum JD. Creamatocrit: simple clinical technique for estimating fat concentration and energy value of human milk. Br Med J. 1978 Apr 22;1(6119):1018-20. doi: 10.1136/bmj.1.6119.1018.
PMID: 638579
citation: Buttiker V, Fanconi S, Burger R. Chylothorax in children: guidelines for diagnosis and management. Chest. 1999 Sep;116(3):682-7. doi: 10.1378/chest.116.3.682.
PMID: 10492271
citation: Lewis CC, Scott DE, Pantell RH, Wolf MH. Parent satisfaction with children's medical care. Development, field test, and validation of a questionnaire. Med Care. 1986 Mar;24(3):209-15. doi: 10.1097/00005650-198603000-00003.
PMID: 3951263
citation: Berseth CL, Mitmesser SH, Ziegler EE, Marunycz JD, Vanderhoof J. Tolerance of a standard intact protein formula versus a partially hydrolyzed formula in healthy, term infants. Nutr J. 2009 Jun 19;8:27. doi: 10.1186/1475-2891-8-27.
PMID: 19545360
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Cindi Farnstrom
investigator title: Certified Pediatric Nurse Practitioner
mesh term: Pleural Effusion
mesh term: Chylothorax