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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02577419
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : April 20, 2018
Sponsor:
Collaborators:
Labatt Family Heart Centre
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Deborah O'Connor, The Hospital for Sick Children

Brief 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.

Condition or disease Intervention/treatment Phase
Chylothorax Other: Target Fortification Other: Higher Initial Concentration Other: Portagen Formula Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Optimizing Growth in Infants Receiving Modified Fat Breast Milk for the Treatment of Chylothorax Following Cardiothoracic Surgery
Study Start Date : October 2015
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Arm Intervention/treatment
Experimental: Target Fortification Other: Target Fortification
Experimental: Higher Initial Concentration Other: Higher Initial Concentration
Active Comparator: Portagen Growth Reference Other: Portagen Formula



Primary Outcome Measures :
  1. Growth - weight [ Time Frame: Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient ]
    z-score for weight-for-age

  2. Growth - length [ Time Frame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient ]
    z-score for length-for-age

  3. 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


Secondary Outcome Measures :
  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 [ Time Frame: Throughout chylothorax treatment (average 6 weeks); daily in hospital ]
    ml/kg/day

  6. Duration of chest tube drainage [ Time Frame: Throughout chylothorax treatment (average 6 weeks); daily in hospital ]
    measured in post-operative days

  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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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577419


Locations
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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Labatt Family Heart Centre
Canadian Institutes of Health Research (CIHR)
Investigators
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Principal Investigator: Deborah L O'Connor, PhD RD The Hospital for Sick Children
Principal Investigator: Sara DiLauro, MSc(c) RD The Hospital for Sick Children
Principal Investigator: Jennifer Russell, MD The Hospital for Sick Children
Publications:
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Responsible Party: Deborah O'Connor, Senior Associate Scientist, Physiology and Experimental Medicine, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02577419    
Other Study ID Numbers: 1000048134
First Posted: October 16, 2015    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Keywords provided by Deborah O'Connor, The Hospital for Sick Children:
breast milk
chylothorax
infants
cardiac surgery
modified fat breast milk
Additional relevant MeSH terms:
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Chylothorax
Pleural Diseases
Respiratory Tract Diseases