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

Chylothorax Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02577419
• Other study ID #: 1000048134
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: August 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Chylothorax

Intervention

Other:
• Target Fortification

• Higher Initial Concentration

• Portagen Formula

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Canadian Institutes of Health Research (CIHR), Labatt Family Heart Centre

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Growth - weight	z-score for weight-for-age	Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient
Primary	Growth - length	z-score for length-for-age	Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Primary	Growth - head circumference	z-score for head circumference-for-age	Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Secondary	Feed volume intakes		Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Secondary	Energy intakes		Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Secondary	Protein intakes		Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
Secondary	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
Secondary	Volume of chest tube drainage	ml/kg/day	Throughout chylothorax treatment (average 6 weeks); daily in hospital
Secondary	Duration of chest tube drainage	measured in post-operative days	Throughout chylothorax treatment (average 6 weeks); daily in hospital
Secondary	Morbidities - hospital re-admission(s)		Throughout chylothorax treatment (average 6 weeks)
Secondary	Morbidities - reaccumulation of chylous fluid		Throughout chylothorax treatment (average 6 weeks)
Secondary	Morbidities - prevalence of serious adverse events		Throughout chylothorax treatment (average 6 weeks)