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

NCT02577419 | Completed

• 1 other identifier: 1000048134
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Chylothorax

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (9)

• 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

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

Study Arms (3)

Target Fortification

EXPERIMENTAL

Other: Target Fortification

Higher Initial Concentration

EXPERIMENTAL

Other: Higher Initial Concentration

Portagen Growth Reference

ACTIVE COMPARATOR

Other: Portagen Formula

Interventions

Target Fortification OTHER

Target Fortification

Higher Initial Concentration OTHER

Higher Initial Concentration

Portagen Formula OTHER

Portagen Growth Reference

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead
• Labatt Family Heart Centre: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (2)

• 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.

  PMID: 25560680 BACKGROUND

• 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.

  PMID: 32690156 BACKGROUND

MeSH Terms

Conditions

Chylothorax

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Deborah L O'Connor, PhD RD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Sara DiLauro, MSc(c) RD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

• Jennifer Russell, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Associate Scientist, Physiology and Experimental Medicine

Study Record Dates

• First Submitted: October 1, 2015
• First Posted: October 16, 2015
• Study Start: October 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 8, 2021

Record last verified: 2021-08

Locations

CA (1)