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

August 31, 2021 updated by: Deborah O'Connor, The Hospital for Sick Children

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Growth - weight
Time Frame: Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient
z-score for weight-for-age
Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient
Growth - length
Time Frame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
z-score for length-for-age
Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
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
Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feed volume intakes
Time Frame: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
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
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
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
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
Throughout chylothorax treatment (average 6 weeks); daily in hospital
Duration of chest tube drainage
Time Frame: Throughout chylothorax treatment (average 6 weeks); daily in hospital
measured in post-operative days
Throughout chylothorax treatment (average 6 weeks); daily in hospital
Morbidities - hospital re-admission(s)
Time Frame: Throughout chylothorax treatment (average 6 weeks)
Throughout chylothorax treatment (average 6 weeks)
Morbidities - reaccumulation of chylous fluid
Time Frame: Throughout chylothorax treatment (average 6 weeks)
Throughout chylothorax treatment (average 6 weeks)
Morbidities - prevalence of serious adverse events
Time Frame: Throughout chylothorax treatment (average 6 weeks)
Throughout chylothorax treatment (average 6 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Hospital for Sick Children

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Canadian Institutes of Health Research (CIHR)
Labatt Family Heart Centre

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1000048134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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