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

Not Applicable

Completed

• Conditions: Chylothorax
• Interventions: Other: Higher Initial Concentration; Other: Portagen Formula; Other: Target Fortification

• Registration Number: NCT02577419
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-10-01
• Study First Submitted QC: 2015-10-13
• Study First Posted: 2015-10-16
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-31
• Last Update Posted: 2021-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Higher Initial Concentration	Higher Initial Concentration	-
Portagen Growth Reference	Portagen Formula	-
Target Fortification	Target Fortification	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada