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

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.

Study Overview

• Status: Completed
• Conditions: Chylothorax
• Intervention / Treatment: Other: Target Fortification; Other: Higher Initial Concentration; Other: Portagen Formula

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth - weight	z-score for weight-for-age	Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient
Growth - length	z-score for length-for-age	Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Growth - head circumference	z-score for head circumference-for-age	Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feed volume intakes		Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Energy intakes		Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Protein intakes		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))		Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient
Volume of chest tube drainage	ml/kg/day	Throughout chylothorax treatment (average 6 weeks); daily in hospital
Duration of chest tube drainage	measured in post-operative days	Throughout chylothorax treatment (average 6 weeks); daily in hospital
Morbidities - hospital re-admission(s)		Throughout chylothorax treatment (average 6 weeks)
Morbidities - reaccumulation of chylous fluid		Throughout chylothorax treatment (average 6 weeks)
Morbidities - prevalence of serious adverse events		Throughout chylothorax treatment (average 6 weeks)

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Canadian Institutes of Health Research (CIHR); Labatt Family Heart Centre
• Investigators: Principal Investigator: Deborah L O'Connor, PhD RD, The Hospital for Sick Children; Principal Investigator: Jennifer Russell, MD, The Hospital for Sick Children; Principal Investigator: Sara DiLauro, MSc(c) RD, The Hospital for Sick Children

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: October 1, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Actual): September 8, 2021
• Last Update Submitted That Met QC Criteria: August 31, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: cardiac surgery; infants; breast milk; chylothorax; modified fat breast milk
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Chylothorax
• Other Study ID Numbers: 1000048134