Impact of Dietary Sodium Supplementation on Growth & Intestinal Microbiome in Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Preterm infant weight gain
研究概览
简要总结
The purpose of this project is to determine the direct impact of sodium supplementation in preterm infants and to see the overall improvement of their growth and health status.
from this study will help us develop a better treatment for in the future.
详细描述
Premature infants are at an increased risk of postnatal growth failure and as well as developing short or long-term impaired neurodevelopment and cardio metabolic health.
For many years, it has been recognized that ideal growth is attainable with sufficient sodium intake and a positive sodium balance. The results of this study could have a significant impact on the care of preterm infants.
Infants will be randomized into one of two groups. One group will receive sodium supplementation as guided by a urine sodium concentration algorithm, one group will be managed by current standards. Randomization will occur at 2 weeks of postnatal age
Standard of care group Care for the participant will remain the same as if they were not in the study. Nutritional information, including sodium intake will be collected on three separate days weekly for 8 weeks. Stool samples will be collected for determining intestinal microbiome at 2 weeks, 5 weeks, 8 weeks and the day they are discharged from the hospital.
The study team will also collect detailed health information from participants hospital stay from the medical chart. Which will include gestational age, birth weight, sex, race ,ethnicity, mode of delivery and exposure to any steroids, antibiotics and clinical diagnoses.
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
- None
入排标准
- 年龄范围
- 25 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Birthweight >500 grams and
- •Gestational age at least 25 0/7weeks but less than 30 weeks.
- •<14 days of age at time of randomization
排除标准
- •Non-English speaking parents
- •Major congenital anomalies
- •grade underlying renal dysfunction (serum creatinine > 1.0 mg/dL or increase of >0.3 mg/DL between any two consecutive measurements)
- •use of diuretics at the time initiation of intervention (approximately 14 days of age) But this is not completely an exclusion-the research can wait 2 days and at the time of 2 week time period of the study we can re check their levels
- •any structural genitourinary criteria.
研究组 & 干预措施
Control
Subjects will be cared for by current protocols
Sodium algorithm
Starting at 2 weeks of age, the sodium algorithm group will be started based on their sodium levels. This will be adjusted weekly based on weight gain and sodium levels.
干预措施: Sodium algorithm (Procedure)
结局指标
主要结局
Preterm infant weight gain
时间窗: 8 weeks
To determine the relationship among sodium intake, bodily growth and the gut in preterm infants
次要结局
- Microbiome(8 weeks)
研究者
Jeffrey Segar
Principal Investigator
Medical College of Wisconsin