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CompletedNCT02577419Updated Sep 8, 2021

Optimizing Growth in Infants Receiving Modified Fat Breast Milk for the Treatment of Chylothorax

An interventional study of Target Fortification and Higher Initial Concentration in Chylothorax, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged Up to 12 Months. Per ClinicalTrials.gov, last updated 2021-09-08.

Sponsored by The Hospital for Sick Children · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
Up to 12 Months
Sex
All
01

Study 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. 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.

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Conditions studied

  • Chylothorax

Keywords

  • breast milk
  • chylothorax
  • infants
  • cardiac surgery
  • modified fat breast milk
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In context

Lead sponsor

The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 12 Months
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    Target Fortification

    Other: Target Fortification

  • Experimental
    Higher Initial Concentration

    Other: Higher Initial Concentration

  • Active comparator
    Portagen Growth Reference

    Other: Portagen Formula

Interventions

  • OtherTarget Fortification
  • OtherHigher Initial Concentration
  • OtherPortagen Formula
06

What researchers measure

Primary outcomes

  1. Growth - weight

    z-score for weight-for-age

    Time frame: Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient

  2. Growth - length

    z-score for length-for-age

    Time frame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient

  3. Growth - head circumference

    z-score for head circumference-for-age

    Time frame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient

Secondary outcomes

  1. Feed volume intakes

    Time frame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient

  2. Energy intakes

    Time frame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient

  3. Protein intakes

    Time frame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient

  4. 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

  5. Volume of chest tube drainage

    ml/kg/day

    Time frame: Throughout chylothorax treatment (average 6 weeks); daily in hospital

  6. Duration of chest tube drainage

    measured in post-operative days

    Time frame: Throughout chylothorax treatment (average 6 weeks); daily in hospital

  7. Morbidities - hospital re-admission(s)

    Time frame: Throughout chylothorax treatment (average 6 weeks)

  8. Morbidities - reaccumulation of chylous fluid

    Time frame: Throughout chylothorax treatment (average 6 weeks)

  9. Morbidities - prevalence of serious adverse events

    Time frame: Throughout chylothorax treatment (average 6 weeks)

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Study locations

1 site
  • The Hospital for Sick Children
    Toronto, Ontario M5G 1X8, Canada
08

References and documents

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 25560680 ↗
  • DiLauro 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02577419
Lead sponsor
The Hospital for Sick Children
Collaborators
Labatt Family Heart Centre, Canadian Institutes of Health Research (CIHR)
Responsible party
Deborah O'Connor (Senior Associate Scientist, Physiology and Experimental Medicine, The Hospital for Sick Children) — Principal investigator
First posted
Oct 16, 2015
Start date
Oct 2015
Primary completion
Oct 2017
Completion
Oct 2017
Last update
Sep 8, 2021

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.

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