Phosphatidylcholine Supplementation in Infants With Diminished Sensory Gating
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Ratio of P50 auditory sensory gating
研究概览
简要总结
Sensory gating is defined as the automatic process of inhibiting brain response to repeated auditory sounds. Infants who brains respond similarly to two identical sounds presented about 1/2 second apart are more likely to have later problems with attention than infants who suppress response to the second sound. This study will examine whether providing a nutritional supplement, phosphatidylcholine, for two months in infancy will result in an increased likelihood of developing more robust sensory gating.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Week 至 7 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy infant has an age (adjusted for gestational age at birth) of 1-7 weeks
- •Diminished P50 sensory gating (ratio greater than or equal to 0.50)
排除标准
- •No maternal reported tobacco use for greater than 1 year and no current tobacco use (as measured by urine cotinine levels)
- •Trimethylaminuria, renal disease, liver disease, known chromosomal abnormality, chronic neurological disorder, premature birth, prenatal exposure to exogenous steroid use
研究组 & 干预措施
phosphatidylcholine supplementation
Phosphatidylcholine supplementation to be administered BID for 8 weeks
干预措施: phosphatidylcholine supplementation (Drug)
placebo supplementation
Placebo to be administered BID for 8 weeks
干预措施: placebo (Drug)
结局指标
主要结局
Ratio of P50 auditory sensory gating
时间窗: 8 weeks post initiation of treatment
In an auditory evoked potential paradigm while in active sleep (the infant equivalent of rapid eye movement sleep) with two identical sounds presented 500 ms apart, the ratio of the amplitude of the P50 response to the second sound divided by the amplitude of the P50 response to the first sound.
次要结局
- Incidence of adverse events(4 weeks and 8 weeks after initiation of intervention)