ChylothoraxNCT02143557
Dietary Treatment of Infants With Chylothorax
A study testing Fat-Modified Breast Milk and MCT formula in people with Chylothorax, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Chylothorax occurs in ~3 to 5 % of infants undergoing cardiac surgery. Standard treatment requires discontinuation of breast milk feeding, due to the abundance of long chain triglycerides, and transition to a medium chain triglyceride (MCT) based formula. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Chylothorax
- What is being tested?
- Fat-Modified Breast Milk and MCT formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Feb 2010
- 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 Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants < 12 months of age who were diagnosed with chylothorax.
- Infants included in the intervention group (MBM) needed to have received >80% of their enteral feeds as breast milk prior to surgery.
- Infants included in the control group (MCT-formula) needed to have received <80% of their enteral feeds as breast milk prior to surgery.
Who cannot join
- Subjects were excluded if their diagnosis made it unlikely that they would be able to follow the hospital's standard 6 week protocol for treatment of chylothorax
- Were receiving only parenteral nutrition at the time of diagnosis of chylothorax
- Primary caregiver of the baby did not have good comprehension of English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Low Fat Breast Milk for the Treatment of Chylothorax in Infants Following Cardiothoracic Surgery: A Pilot Study
Chylothorax occurs in ~3 to 5 % of infants undergoing cardiac surgery. Standard treatment requires discontinuation of breast milk feeding, due to the abundance of long chain triglycerides, and transition to a medium chain triglyceride (MCT) based formula. Objective: To determine the effectiveness of fat-modified breast milk (MBM) for the treatment of chylothorax compared with MCT-formula. Hypothesis: The investigators primary hypothesis was that infants fed MBM would have more chyle drainage in the first 5 days after diagnosis compared to infants fed an MCT based formula which is the current standard of care. Design: Infants with chylothorax were eligible. Treatment infants (n=8) received mother's own milk that had been modified by removing the fat layer via centrifugation and adding MCT and nutrients to provide 67 kcal/mL and 11 g/100 mL protein (MBM group). Control infants (n=8) received an MCT-formula (MCT group). The feeding intervention was a minimum of 6 weeks after chest tube removal per The Hospital for Sick Children standard chylothorax treatment protocol. Outcome measures collected included chyle drainage from chest tubes, weight, length and head circumference measurements and estimated energy and nutrient intake.
- Conditions
- Chylothorax
- Being tested
- Fat-Modified Breast Milk, MCT formula
- Keywords
- breast milk, infants, chylothorax, cardiac surgery, modified breast milk
- Medical subject headings
- Chylothorax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat-Modified Breast MilkOther
MCT formulaOther
| Study group | Role | What they receive |
|---|---|---|
| Fat-Modified Breast Milk | Experimental | Infants in this arm of the study were fed their own mother's breast milk where the fat layer was removed by centrifugation. Prior to feeding, extra energy and nutrients were added to the defatted breast milk. Receives: Other: Fat-Modified Breast Milk |
| MCT-formula group | Active comparator | Infants in this arm of the study were fed a MCT-containing medical food which is the current standard of care. Receives: Other: MCT formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chyle Drainage from Chest Tubes
This outcome includes measurement of chyle drainage from chest tubes in the first 5 days after diagnosis of chylothorax and the number of days of chest tube drainage.
Measured: 6 weeks of chylothorax treatment
Secondary outcomes (1)
Growth
Infant weight, length and head circumference measurements were determined at study initiation and at the first post-discharge follow-up visit (within one-week of discharge) and again at the end of chylothorax treatment.
Measured: 6 weeks of the chylothorax treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startJan 2008
- Primary completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChylothoraxStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Labatt Family Heart Centre, Trainee award through Ontario Student Opportunity Trust Fund - The Hospital for Sick Children Foundation Scholarship
- Responsible party
- Principal investigator, Deborah O'Connor, The Hospital for Sick Children
- Investigators
- Deborah L O'Connor, PhD RD, Principal investigator, The Hospital for Sick ChildrenSarah Kocel, MSc RD, Principal investigator, The Hospital for Sick ChildrenJennifer Russell, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143557
- Sponsor's protocol ID
- 1000011037
- Other IDs
- 1000037303
- Status last verified
- May 2014
- First submitted
- 12 May 2014
- Last updated
- 21 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Low Fat Breast Milk for the Treatment of Chylothorax in Infants Following Cardiothoracic Surgery: A Pilot Study
- ClinicalTrials.gov ID
- NCT02143557
- Acronym / sponsor ID
- 1000011037
- Conditions
- Chylothorax
- Keywords
- breast milk, infants, chylothorax, cardiac surgery, modified breast milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Labatt Family Heart Centre, Trainee award through Ontario Student Opportunity Trust Fund - The Hospital for Sick Children Foundation Scholarship
- Study start
- Jan 2008
- Primary completion
- Feb 2010 (actual)
- First posted
- 21 May 2014 (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.
Chylothorax occurs in ~3 to 5 % of infants undergoing cardiac surgery. Standard treatment requires discontinuation of breast milk feeding, due to the abundance of long chain triglycerides, and transition to a medium chain triglyceride (MCT) based formula. Objective: To determine the effectiveness of fat-modified breast milk (MBM) for the treatment of chylothorax compared with MCT-formula. Hypothesis: The investigators primary hypothesis was that infants fed MBM would have more chyle drainage in the first 5 days after diagnosis compared to infants fed an MCT based formula which is the current standard of care. Design: Infants with chylothorax were eligible. Treatment infants (n=8) received mother's own milk that had been modified by removing the fat layer via centrifugation and adding MCT and nutrients to provide 67 kcal/mL and 11 g/100 mL protein (MBM group). Control infants (n=8) received an MCT-formula (MCT group). The feeding intervention was a minimum of 6 weeks after chest tube removal per The Hospital for Sick Children standard chylothorax treatment protocol. Outcome measures collected included chyle drainage from chest tubes, weight, length and head circumference measurements and estimated energy and nutrient intake.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fat-Modified Breast Milk | Experimental | Other: Fat-Modified Breast MilkInfants in this arm of the study were fed their own mother's breast milk where the fat layer was removed by centrifugation. Prior to feeding, extra energy and nutrients were added to the defatted breast milk. |
| MCT-formula group | Active comparator | Other: MCT formulaInfants in this arm of the study were fed a MCT-containing medical food which is the current standard of care. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants < 12 months of age who were diagnosed with chylothorax.
- Infants included in the intervention group (MBM) needed to have received >80% of their enteral feeds as breast milk prior to surgery.
- Infants included in the control group (MCT-formula) needed to have received <80% of their enteral feeds as breast milk prior to surgery.
Key exclusion criteria (3 listed)
- Subjects were excluded if their diagnosis made it unlikely that they would be able to follow the hospital's standard 6 week protocol for treatment of chylothorax
- Were receiving only parenteral nutrition at the time of diagnosis of chylothorax
- Primary caregiver of the baby did not have good comprehension of English.
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 |
|---|---|---|
| Fat-Modified Breast Milk | Other | Fat-Modified Breast Milk |
| MCT formula | Other | MCT-formula group |
Primary outcome
Chyle Drainage from Chest Tubes
Time frame: 6 weeks of chylothorax treatment
This outcome includes measurement of chyle drainage from chest tubes in the first 5 days after diagnosis of chylothorax and the number of days of chest tube drainage.
1 secondary outcome
Growth
Time frame: 6 weeks of the chylothorax treatment
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 21 May 2014.
Related trials for Chylothorax
Recruiting
Olive Oil Before Lung Cancer Surgery to Prevent Chylothorax
Lung Cancer, Chylothorax
RecruitingObservational study
European Registry Study on Lymphatic Interventions
Lymphatic Disorders, Plastic Bronchitis
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.
Deborah L O'Connor, PhD RD principal investigator
The Hospital for Sick Children
Sarah Kocel, MSc RD principal investigator
The Hospital for Sick Children
Jennifer Russell, MD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fat-Modified Breast Milk and MCT formula in people with Chylothorax, run by The Hospital for Sick Children at 1 site in Canada.
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 3 inclusion and 3 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 21 May 2014. 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 Canada. 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?
Chyle Drainage from Chest Tubes (time frame: 6 weeks of chylothorax treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2014.