Protein Supplementation in Infants With Brain Injury
To date, few studies have been done regarding nutrition supplementation in infants with brain injury. Therefore, the investigators are proposing to study the effects of protein supplementation in this group of babies. The investigators will recruit 24 infants with brain injury (evidence of hemorrhage, white matter injury, or gray matter injury) admitted to the Cincinnati Children's Hospital Neonatal Intensive Care Unit (NICU) into the study. Upon diagnosis, the investigators will obtain consent from the parents for participation in the study, then randomly assign the baby to one of two groups - an increased protein group and a control group. Both groups of infants will be monitored to ensure no adverse effects occur due to the supplementation.
Protein supplementation will continue for the first 12 months of age. Growth parameters, such as weight, length, and head circumference, will be measured while the infant is the NICU. Head circumference will be measured in the investigators outpatient clinic at three, six, and 12 months of age. At 18-22 months, the infants will be tested for neurodevelopmental outcomes using the Bayley Scales of Infant Development. The investigators hypothesize that infants who receive the additional protein will demonstrate increased head growth and improved neurodevelopmental outcomes.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Ohio
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Cincinnati、Ohio、美国、45229
- Cincinnati Children's Hospital Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Infants admitted to the NICU at CCHMC
- Known or suspected brain injury
- Parental consent obtained
- At least 48 hours of age at the time of randomization
Exclusion Criteria:
- Congenital or posthemorrhagic hydrocephalus
- Major congenital brain malformations
- Congenital gastrointestinal malformations or Bell Stage III NEC
- Inborn errors of metabolism
- Chromosomal abnormalities
- Significant cardiac disease
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Increased protein
Full term infants will be on 4 g/kg/day of protein.
Preterm infants will be on 4.5 g/kg/day of protein until term corrected age.
Beneprotein powder will be used; if this is not tolerated, Complete Amino Acids will be used.
Max protein will be 30 g/day.
Increased protein will be given until 12 months corrected age.
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其他名称:
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无干预:Standard diet
Infants will be given a usual diet.
If infants in this arm have poor growth, protein or caloric supplementation may be given per the discretion of the clinical team.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Head circumference
大体时间:12 months of age +/- 4 weeks
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12 months of age +/- 4 weeks
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Neurodevelopmental outcome on Bayley Scales of Infant Development
大体时间:18-22 months
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18-22 months
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Weight and length
大体时间:3, 6, 12 months of age
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3, 6, 12 months of age
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Blood urea nitrogen
大体时间:10 and 30 days post study initiation
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10 and 30 days post study initiation
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CO2 from renal panel
大体时间:10 and 30 days post study initiation
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To assess for metabolic acidosis
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10 and 30 days post study initiation
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合作者和调查者
调查人员
- 首席研究员:Stephanie Merhar, MD、Children's Hospital Medical Center, Cincinnati
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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