Optimizing Growth in Infants Receiving Modified Fat Breast Milk for the Treatment of Chylothorax Following Cardiothoracic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Growth - length
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Growth - length
时间窗: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
z-score for length-for-age
Growth - weight
时间窗: Throughout chylothorax treatment (average 6 weeks); daily in hospital; weekly as outpatient
z-score for weight-for-age
Growth - head circumference
时间窗: Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient
z-score for head circumference-for-age
次要结局
- 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)
- Duration of chest tube drainage(Throughout chylothorax treatment (average 6 weeks); daily in hospital)
- Morbidities - reaccumulation of chylous fluid(Throughout chylothorax treatment (average 6 weeks))
- Morbidities - hospital re-admission(s)(Throughout chylothorax treatment (average 6 weeks))
- Morbidities - prevalence of serious adverse events(Throughout chylothorax treatment (average 6 weeks))
- Energy intakes(Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient)
- Feed volume intakes(Throughout chylothorax treatment (average 6 weeks); calculated daily in hospital; weekly as outpatient)
研究者
Deborah O'Connor
Senior Associate Scientist, Physiology and Experimental Medicine
The Hospital for Sick Children