Neurodevelopmental and Growth Outcomes of Early, Aggressive Protein Intake in Very Low Birthweight Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Number of Participants With Weight<10th Percentile for Age
研究概览
简要总结
The purpose of this study is to determine whether providing increased protein to premature infants in the first week of life allows for better growth during the hospital stay and improved developmental outcomes by age 2.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 18 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •birth weight 400 to 1250 grams
- •24 0/7 to 30 6/7 weeks gestational age
排除标准
- •chromosomal, structural, metabolic, endocrine, or renal abnormalities that could affect growth
- •infants >18 hours of age
- •infants in extremis who are unlikely to survive past 72 hours
研究组 & 干预措施
Standard amino acids
Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day
干预措施: Amino acids (Drug)
High amino acids
Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth
干预措施: Amino acids (Drug)
结局指标
主要结局
Number of Participants With Weight<10th Percentile for Age
时间窗: 36 weeks post-conceptual age
Number of Participants With Length <10th Percentile for Age
时间窗: 36 weeks post-conceptual age
Number of Participants With Head Circumference <10th Percentile for Age
时间窗: 36 weeks post-conceptual age
Cognitive Development Score
时间窗: 18-22 months corrected gestational age
Reported as units on a scale with mean of 100 and a Standard Deviation of 15, and range from 40-160. Higher values indicate a better outcome.
次要结局
- Serum Creatinine(Day of life 1, 2, 3, 5 and 7)
- Serum Blood Urea Nitrogen(Day of life 1, 2, 3, 5 and 7)
- Serum Bicarbonate(Day of life 1, 2, 3, 5 and 7)
研究者
Joseph Bliss
Staff Neonatologist
Women and Infants Hospital of Rhode Island