Chylous Pleural Effusion Following Cardiothoracic SurgeryNCT01673165
Fortified Skimmed Mother's Milk in the Management of Chylothorax
A study testing Skimmed mother's milk and Specialized Formula in people with Chylous Pleural Effusion Following Cardiothoracic Surgery, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 12 months
- Conditions the study is for
- Chylous Pleural Effusion Following Cardiothoracic Surgery
- What is being tested?
- Skimmed mother's milk and Specialized Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant birth to 12 months of age
- Undergo cardiothoracic surgery
- Develop a chylous effusion
- Be a breastfed or formula fed infant
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health and Science University - Doernbecher Children's Hospital
Portland, Oregon, 97239
About this study
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
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.
Read the 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.
- Being tested
- Skimmed mother's milk, Specialized Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skimmed mother's milkOther
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
Specialized FormulaOther
Infants will receive our standard of care - specialized formula
| Study group | Role | What they receive |
|---|---|---|
| Specialized Formula | Active comparator | 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 Receives: Other: Specialized Formula |
| Skimmed mother's milk | Experimental | 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 Receives: Other: Skimmed mother's milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 2 months from enrollment
Secondary outcomes (3)
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.
Measured: up to 4 months after hospital discharge
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.
Measured: the first 30 days after enrollment
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
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Chylous Pleural Effusion Following Cardiothoracic SurgeryStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- The Gerber Foundation
- Responsible party
- Principal investigator, Cindi Farnstrom, Oregon Health and Science University
- Investigators
- Cindi Farnstrom, MN, CPNP, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01673165
- Sponsor's protocol ID
- Gerber7747
- Status last verified
- Oct 2014
- First submitted
- 22 Aug 2012
- Last updated
- 14 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 2061800Milonakis 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.
PubMed 19583606Chan 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.
PubMed 16242470Beghetti 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.
PubMed 10802499Bond 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.
PubMed 8379718Suddaby EC, Schiller S. Management of chylothorax in children. Pediatr Nurs. 2004 Jul-Aug;30(4):290-5.
PubMed 15511045Allen 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.
PubMed 1779326Lessen R. Use of skim breast milk for an infant with chylothorax. ICAN: Infant, Child, & Adolescent Nutrition. 2009; 1(6):303-310.
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.
PubMed 17554391Staats 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.
PubMed 7442324Cormack 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.
PubMed 14726083Orange 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.
PubMed 12970641Sheeran 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.
PubMed 9114643Wang 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.
PubMed 10685254Chatterjee 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.
PubMed 9567552
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01673165
- Acronym / sponsor ID
- Gerber7747
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- The Gerber Foundation
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 27 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Specialized Formula | Active comparator | Other: Specialized Formula25 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 |
| Skimmed mother's milk | Experimental | Other: Skimmed mother's milk25 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 |
Who may qualify
- Ages
- 1 day to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infant birth to 12 months of age
- Undergo cardiothoracic surgery
- Develop a chylous effusion
- Be a breastfed or formula fed infant
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skimmed mother's milkFortified 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 | Other | Skimmed mother's milk |
| Specialized FormulaInfants will receive our standard of care - specialized formula | Other | Specialized Formula |
Primary outcome
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
3 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
To evaluate the technique of skimming and fortifying breast milk
Time frame: the first 30 days after enrollment
To compare feeding tolerance, growth, and nutrition in infants who receive fortified skimmed mother's milk versus specialized formula
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2015.
- Background: PubMed 2061800Le 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.
- Background: PubMed 19583606Milonakis 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.
- Background: PubMed 16242470Chan 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.
- Background: PubMed 10802499Beghetti 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.
- Background: PubMed 8379718Bond 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.
- Background: PubMed 15511045Suddaby EC, Schiller S. Management of chylothorax in children. Pediatr Nurs. 2004 Jul-Aug;30(4):290-5.
- Background: PubMed 1779326Allen 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.
- BackgroundLessen R. Use of skim breast milk for an infant with chylothorax. ICAN: Infant, Child, & Adolescent Nutrition. 2009; 1(6):303-310.
- Background: PubMed 17554391Chan 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.
- Background: PubMed 7442324Staats 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.
- Background: PubMed 14726083Cormack 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.
- Background: PubMed 12970641Orange 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindi Farnstrom, MN, CPNP principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skimmed mother's milk and Specialized Formula in people with Chylous Pleural Effusion Following Cardiothoracic Surgery, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01673165, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2015.