High Versus Standard Dose Protein for Very Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Weight gain
研究概览
简要总结
Although expressed breast milk is considered the optimal nutritional source for preterm infants, the macronutrient content is insufficient to enable optimal growth during neonatal intensive care. Optimal dose and optimal mode of administration (standardized or individualized) of enteral protein supplementation to very preterm infants have not been established.
This study aims to compare the effects on weight gain of different modes of enteral protein supplementation.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •very preterm infants <32 weeks gestation and <1500g birth weight
- •> 100ml/kg/d of enteral feeding
排除标准
- •missing informed consent
- •decision not to feed breast milk
- •congenital malformations
- •age > 7 days at study entry
研究组 & 干预措施
High Dose Protein (Individualized)
Protein supplementation according to breast milk content aiming for 4.5g/kg/d of enteral protein if <1500g b.w. or 4.0g/kg/d of enteral protein if >1500g b.w. until 1 week before discharge
干预措施: High Dose Protein (Individualized) (Dietary Supplement)
High Dose Protein (Standardized)
Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge
干预措施: High Dose Protein (Standardized) (Dietary Supplement)
Standard protein supplementation
Protein supplementation independent of individual breast milk content using a standard dose of a standard breast milk fortifier until 1 week before discharge
干预措施: Standard Protein Supplementation (Dietary Supplement)
结局指标
主要结局
Weight gain
时间窗: From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA)
次要结局
- Head circumference growth(From birth - to the end of study intervention (anticipated to be on average 1 week before discharge home at approx 37 weeks PMA))
研究者
Axel Franz
PD Dr. med.
University Hospital Tuebingen