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

Primary Purpose

Chylothorax

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Target Fortification

Higher Initial Concentration

Portagen Formula

About this trial

This is an interventional supportive care trial for Chylothorax focused on measuring breast milk, chylothorax, infants, cardiac surgery, modified fat breast milk

Eligibility Criteria

undefined - 12 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Hospital for Sick Children

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Target Fortification

Higher Initial Concentration

Portagen Growth Reference

Arm Description

Outcomes

Primary Outcome Measures

Growth - weight

z-score for weight-for-age

Growth - length

z-score for length-for-age

Growth - head circumference

z-score for head circumference-for-age

Secondary Outcome Measures

Feed volume intakes

Energy intakes

Protein intakes

Solid food intakes (type, grams at home measured using a scale (CS2000; Ohaus))

Volume of chest tube drainage

ml/kg/day

Duration of chest tube drainage

measured in post-operative days

Morbidities - hospital re-admission(s)

Morbidities - reaccumulation of chylous fluid

Morbidities - prevalence of serious adverse events

Full Information

NCT ID

NCT02577419

First Posted

October 1, 2015

Last Updated

August 31, 2021

Sponsor

The Hospital for Sick Children

Collaborators

Labatt Family Heart Centre, Canadian Institutes of Health Research (CIHR)

1. Study Identification

Unique Protocol Identification Number

NCT02577419

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2021

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

October 2017 (Actual)

Study Completion Date

October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The Hospital for Sick Children

Collaborators

Labatt Family Heart Centre, Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chylothorax

Keywords

breast milk, chylothorax, infants, cardiac surgery, modified fat breast milk

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Target Fortification

Arm Type

Experimental

Arm Title

Higher Initial Concentration

Arm Type

Experimental

Arm Title

Portagen Growth Reference

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

Target Fortification

Intervention Type

Other

Intervention Name(s)

Higher Initial Concentration

Intervention Type

Other

Intervention Name(s)

Portagen Formula

Primary Outcome Measure Information:

Title

Growth - weight

Description

z-score for weight-for-age

Time Frame

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

Title

Growth - length

Description

z-score for length-for-age

Time Frame

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

Title

Growth - head circumference

Description

z-score for head circumference-for-age

Time Frame

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

Secondary Outcome Measure Information:

Title

Feed volume intakes

Time Frame

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

Title

Energy intakes

Time Frame

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

Title

Protein intakes

Time Frame

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

Title

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

Title

Volume of chest tube drainage

Description

ml/kg/day

Time Frame

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

Title

Duration of chest tube drainage

Description

measured in post-operative days

Time Frame

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

Title

Morbidities - hospital re-admission(s)

Time Frame

Throughout chylothorax treatment (average 6 weeks)

Title

Morbidities - reaccumulation of chylous fluid

Time Frame

Throughout chylothorax treatment (average 6 weeks)

Title

Morbidities - prevalence of serious adverse events

Time Frame

Throughout chylothorax treatment (average 6 weeks)

10. Eligibility

Sex

All

Maximum Age & Unit of Time

12 Months

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Deborah L O'Connor, PhD RD

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sara DiLauro, MSc(c) RD

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jennifer Russell, MD

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

25560680

Citation

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.

Results Reference

background

PubMed Identifier

32690156

Citation

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.

Results Reference

background

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

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