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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Optimizing Growth in Infants Receiving Modified Fat Breast Milk for the Treatment of Chylothorax Following Cardiothoracic Surgery

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.

Detailed Summary:
Sponsor: The Hospital for Sick Children

Current 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: The Hospital for Sick Children

Dates:
Date Received: October 1, 2015
Date Started: October 2015
Date Completion:
Last Updated: June 6, 2016
Last Verified: June 2016