Protein Turnover in Preterm Infants - Feeding of Target Fortified Breast Milk With Different Carbohydrate and Fat Composition to Improve Growth
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- weight gain
研究概览
简要总结
The purpose of this study is to measure protein turnover rates in preterm infants.
详细描述
After being informed about the study and potential risks, all parents giving written informed consent the principal investigator will determine the eligibility for study entry. Patients who met the eligibility requirements will be randomized in a double-blind manner in a 1:1 ratio to fortified breast milk with higher fat composition to fortified breast milk with higher carbohydrate composition. Both groups will receive a stable protein composition. The participants will receive the intervention for 3 consecutive weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Doctors, nurses and parents are blinded to the intervention
入排标准
- 年龄范围
- 23 Weeks 至 32 Weeks（Child）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Gestational age < 32 weeks
- •Enteral nutrition >150 mL / kg / d
排除标准
- •gastrointestinal malformations
- •Enterostoma
- •short bowel syndrome
- •necrotizing enterocolitis
- •kidney disease
- •Foreseeable transfer
结局指标
主要结局
weight gain
时间窗: daily for 3 weeks
weight gain in gram
Protein turnover and net protein gain
时间窗: weekly for 3 weeks
Tracer N15 labelled amino acids
Protein excretion
时间窗: weekly for 3 weeks
Urinary urea in mg/dL and urine volume in mL will be combined to report protein excretion per urine sample (g/kg/d).
次要结局
- Nutritional intake(daily for 3 weeks)
- head circumference(daily for 3 weeks)
- body length(daily for 3 weeks)
- body composition(weekly for 3 weeks)
研究者
Niels Rochow, MD, PhD
Principal Investigator
Paracelsus Medical University