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Completed

NCT Number: NCT02577419

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

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.

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Key information

Conditions

Chylothorax Pleural Diseases Respiratory Tract Diseases

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Target Fortification

Other

Higher Initial Concentration

Other

Portagen Formula

Other

Primary outcomes

  1. Growth - weight

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

    z-score for weight-for-age

  2. Growth - length

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

    z-score for length-for-age

  3. 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

Secondary outcomes

  1. Feed volume intakes

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

  2. Energy intakes

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

  3. Protein intakes

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

  4. 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

  5. Volume of chest tube drainage

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

    ml/kg/day

  6. Duration of chest tube drainage

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

    measured in post-operative days

  7. Morbidities - hospital re-admission(s)

    Time frame: Throughout chylothorax treatment (average 6 weeks)

  8. Morbidities - reaccumulation of chylous fluid

    Time frame: Throughout chylothorax treatment (average 6 weeks)

  9. Morbidities - prevalence of serious adverse events

    Time frame: Throughout chylothorax treatment (average 6 weeks)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Oct 16, 2015
Registry last updated
Sep 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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