Randomized Controlled Trial of Parenteral Glutamine Supplementation for Extremely-Low-Birth-Weight (ELBW) Infants
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,433
- 试验地点
- 15
- 主要终点
- Death or late-onset sepsis
研究概览
简要总结
This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm) infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings.
详细描述
Meeting the protein and energy requirements of extremely premature infants in early postnatal life requires early hyperalimentation and the gradual introduction of enteral feedings. Glutamine, which is the most abundant amino acid in the human body and taken up in greatest quantity by the fetus from the placenta, is not routinely provided in neonatal parenteral nutrition preparations.
This large multicenter double-masked clinical trial tested whether supplementation of standard neonatal parenteral nutrition with glutamine would reduce the risk of death or late-onset sepsis in extremely-low-birth-weight (ELBW, less than or equal to 1000 gm) infants. Neonates with birth weights of 401-1000gm were randomized to standard TrophAmine or TrophAmine supplemented with glutamine before 72 hours and continued until the infants are tolerating full enteral feedings.
Infants received a neurodevelopmental assessment by masked, certified examiners at 18-22 months postmenstrual age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 72 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •401-1000 gm
- •More than 12 hrs and less than 72 hrs after birth; intravenous access
- •Parental consent
排除标准
- •One or more major congenital anomalies
- •Infants meeting criteria for terminal illness
- •Congenital nonbacterial infection with overt signs at birth
研究组 & 干预措施
Glutamine
TrophAmine (B. Braun/McGaw) with cysteine hydrochloride (40mg/gm amino acids) with L-glutamine added (20% of the total amount of amino acids)
干预措施: Glutamine (Drug)
Placebo
Standard TrophAmine (B. Braun/McGaw) with cysteine hydrochloride (40mg/gm amino acids)
干预措施: Placebo (Drug)
结局指标
主要结局
Death or late-onset sepsis
时间窗: At hospital discharge
次要结局
- Growth (days to reach 1500 grams)(At hospital discharge)
- Number of days on parenteral nutrition(At hospital discharge)
- Levels of pro-inflammatory cytokines(In the perinatal period)
- Episodes of late-onset sepsis(At hospital discharge)
- Neurodevelopmental outcome(18-22 months corrrected age)
- Tolerance of enteral feeding (number of days to reach full enteral feeds) and decrease number of episodes of feeding intolerance(At hospital discharge)
- Necrotizing Enterocolitis(At hospital discharge)
- Length of stay in NICU(At hospital discharge)