ChylothoraxNCT02577419
Optimizing Growth in Infants Receiving Modified Fat Breast Milk for the Treatment of Chylothorax
A study testing Target Fortification, Higher Initial Concentration and Portagen Formula in people with Chylothorax, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
Breast milk is the reference normative standard for infant feeding. When an infant is diagnosed with chylothorax, provision of breast milk must be temporarily discontinued due to the presence of long chain triglycerides (LCT) that contribute to persistent chylous drainage. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Chylothorax
- What is being tested?
- Target Fortification, Higher Initial Concentration and Portagen Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Oct 2017
- 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
- confirmed diagnosis of chylothorax following cardiothoracic surgery
- previously receiving a minimum of 50% of feeds from breast milk 3 days prior to surgical procedure
- parents/caregivers would like to continue to provide breast milk during chylothorax treatment
Who cannot join
- diagnoses of chylothorax classified as either congenital, obstructive, or traumatic not following cardiothoracic surgery
- patient has a chromosomal anomaly that affects growth (i.e. Trisomy 21, Trisomy 18 etc.)
- patient receiving less than 50% of feeds from breast milk (or mother does not have intention to provide breast milk)
- neither parent/caregiver/family member able to communicate effectively in English
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Growth in Infants Receiving Modified Fat Breast Milk for the Treatment of Chylothorax Following Cardiothoracic Surgery
Breast milk is the reference normative standard for infant feeding. When an infant is diagnosed with chylothorax, provision of breast milk must be temporarily discontinued due to the presence of long chain triglycerides (LCT) that contribute to persistent chylous drainage. In its place, the infant is prescribed a therapeutic formula high in medium chain triglycerides (MCT) as treatment for chylothorax. Families and health care providers are interested in using breast milk, in a modified fat form, as treatment for chylothorax instead. This study will assess growth in infants receiving one of two nutrient enriched modified fat breast milk (MFBM) treatments for chylothorax. If either of the proposed nutrient enrichment methods support growth, MFBM will become a standard chylothorax treatment option for infants at SickKids.
- Conditions
- Chylothorax
- Being tested
- Target Fortification, Higher Initial Concentration, Portagen Formula
- Keywords
- breast milk, chylothorax, infants, cardiac surgery, modified fat 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.
Target FortificationOther
Higher Initial ConcentrationOther
Portagen FormulaOther
| Study group | Role | What they receive |
|---|---|---|
| Target Fortification | Experimental | Not described Receives: Other: Target Fortification |
| Higher Initial Concentration | Experimental | Not described Receives: Other: Higher Initial Concentration |
| Portagen Growth Reference | Active comparator | Not described Receives: Other: Portagen Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Growth - weight
z-score for weight-for-age
Measured: Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient
Growth - length
z-score for length-for-age
Measured: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Growth - head circumference
z-score for head circumference-for-age
Measured: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Secondary outcomes (9)
Feed volume intakes
Measured: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Energy intakes
Measured: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Protein intakes
Measured: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Solid food intakes (type, grams at home measured using a scale (CS2000; Ohaus))
Measured: Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient
Volume of chest tube drainage
ml/kg/day
Measured: Throughout chylothorax treatment (average 6 weeks); daily in hospital
Duration of chest tube drainage
measured in post-operative days
Measured: Throughout chylothorax treatment (average 6 weeks); daily in hospital
Morbidities - hospital re-admission(s)
Measured: Throughout chylothorax treatment (average 6 weeks)
Morbidities - reaccumulation of chylous fluid
Measured: Throughout chylothorax treatment (average 6 weeks)
Morbidities - prevalence of serious adverse events
Measured: Throughout chylothorax treatment (average 6 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ChylothoraxStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Labatt Family Heart Centre, Canadian Institutes of Health Research (CIHR)
- 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 ChildrenSara DiLauro, MSc(c) RD, Principal investigator, The Hospital for Sick ChildrenJennifer Russell, MD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577419
- Sponsor's protocol ID
- 1000048134
- Status last verified
- Aug 2021
- First submitted
- 1 Oct 2015
- Last updated
- 8 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Kocel SL, Russell J, O'Connor DL. Fat-Modified Breast Milk Resolves Chylous Pleural Effusion in Infants With Postsurgical Chylothorax but Is Associated With Slow Growth. JPEN J Parenter Enteral Nutr. 2016 May;40(4):543-51. doi: 10.1177/0148607114566464. Epub 2015 Jan 5.
PubMed 25560680DiLauro S, Russell J, McCrindle BW, Tomlinson C, Unger S, O'Connor DL. Growth of cardiac infants with post-surgical chylothorax can be supported using modified fat breast milk with proactive nutrient-enrichment and advancement feeding protocols; an open-label trial. Clin Nutr ESPEN. 2020 Aug;38:19-27. doi: 10.1016/j.clnesp.2020.05.001. Epub 2020 May 23.
PubMed 32690156
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Growth in Infants Receiving Modified Fat Breast Milk for the Treatment of Chylothorax Following Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT02577419
- Acronym / sponsor ID
- 1000048134
- Conditions
- Chylothorax
- Keywords
- breast milk, chylothorax, infants, cardiac surgery, modified fat breast milk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Labatt Family Heart Centre, Canadian Institutes of Health Research (CIHR)
- Study start
- Oct 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 16 Oct 2015 (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.
Breast milk is the reference normative standard for infant feeding. When an infant is diagnosed with chylothorax, provision of breast milk must be temporarily discontinued due to the presence of long chain triglycerides (LCT) that contribute to persistent chylous drainage. In its place, the infant is prescribed a therapeutic formula high in medium chain triglycerides (MCT) as treatment for chylothorax. Families and health care providers are interested in using breast milk, in a modified fat form, as treatment for chylothorax instead. This study will assess growth in infants receiving one of two nutrient enriched modified fat breast milk (MFBM) treatments for chylothorax. If either of the proposed nutrient enrichment methods support growth, MFBM will become a standard chylothorax treatment option for infants at SickKids.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Target Fortification | Experimental | Other: Target Fortification |
| Higher Initial Concentration | Experimental | Other: Higher Initial Concentration |
| Portagen Growth Reference | Active comparator | Other: Portagen Formula |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- confirmed diagnosis of chylothorax following cardiothoracic surgery
- previously receiving a minimum of 50% of feeds from breast milk 3 days prior to surgical procedure
- parents/caregivers would like to continue to provide breast milk during chylothorax treatment
Key exclusion criteria (4 listed)
- diagnoses of chylothorax classified as either congenital, obstructive, or traumatic not following cardiothoracic surgery
- patient has a chromosomal anomaly that affects growth (i.e. Trisomy 21, Trisomy 18 etc.)
- patient receiving less than 50% of feeds from breast milk (or mother does not have intention to provide breast milk)
- neither parent/caregiver/family member able to communicate effectively in 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 |
|---|---|---|
| Target Fortification | Other | Target Fortification |
| Higher Initial Concentration | Other | Higher Initial Concentration |
| Portagen Formula | Other | Portagen Growth Reference |
Primary outcome
Growth - weight
Time frame: Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient
z-score for weight-for-age
Growth - length
Time frame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
z-score for length-for-age
Growth - head circumference
Time frame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
z-score for head circumference-for-age
9 secondary outcomes
Feed volume intakes
Time frame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Energy intakes
Time frame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Protein intakes
Time frame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Solid food intakes (type, grams at home measured using a scale (CS2000; Ohaus))
Time frame: Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient
Volume of chest tube drainage
Time frame: Throughout chylothorax treatment (average 6 weeks); daily in hospital
Duration of chest tube drainage
Time frame: Throughout chylothorax treatment (average 6 weeks); daily in hospital
Morbidities - hospital re-admission(s)
Time frame: Throughout chylothorax treatment (average 6 weeks)
Morbidities - reaccumulation of chylous fluid
Time frame: Throughout chylothorax treatment (average 6 weeks)
Morbidities - prevalence of serious adverse events
Time frame: Throughout chylothorax treatment (average 6 weeks)
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 8 Sep 2021.
- Background: PubMed 25560680Kocel SL, Russell J, O'Connor DL. Fat-Modified Breast Milk Resolves Chylous Pleural Effusion in Infants With Postsurgical Chylothorax but Is Associated With Slow Growth. JPEN J Parenter Enteral Nutr. 2016 May;40(4):543-51. doi: 10.1177/0148607114566464. Epub 2015 Jan 5.
- Background: PubMed 32690156DiLauro S, Russell J, McCrindle BW, Tomlinson C, Unger S, O'Connor DL. Growth of cardiac infants with post-surgical chylothorax can be supported using modified fat breast milk with proactive nutrient-enrichment and advancement feeding protocols; an open-label trial. Clin Nutr ESPEN. 2020 Aug;38:19-27. doi: 10.1016/j.clnesp.2020.05.001. Epub 2020 May 23.
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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
Sara DiLauro, MSc(c) 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 Target Fortification, Higher Initial Concentration and Portagen 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 4 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 8 Sep 2021. 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?
Growth - weight (time frame: Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient). The study lists 3 primary outcomes in all. 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 NCT02577419, which also lists 2 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 8 Sep 2021.