Definition of Urinary Creatinine Excretion Time in the Neonatal Period, in Full Term Newborns : a Prospective Monocentric Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Longitudinal changes in urinary creatinine excretion in newborns
研究概览
简要总结
Newborn's renal function is difficult to assess and its physiology during the first days of life is still incompletely known. Studies suggest that the newborn almost completely reabsorbs creatinine during the first 48 to 72 hours of life, while at the same time it continues to produce its own creatinine. Therefore, the initial stock of creatinine at birth still increases through this production and the non or weak clearance. A better knowledge of renal physiopathology in newborns would allow to improve the therapeutic management of the infants, particularly in case of potential nephrotoxicity. No study has attempted to assess the increase in urinary creatinine excretion in neonates from a given time.
Objectives: To show when urinary creatinine excretion in newborns is efficient. Results: this study mightr show an inflection point in urinary creatinine excretion illustrating the postnatal age when renal function becomes efficient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- — 至 3 Days(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All full-term newborns (37WA or more)
- •From a physiological and spontaneous pregnancy
- •Good neonatal adaptation (Apgar 7 at 5 minutes of life)
- •Eutrophic (weight > 10th percentile and < 90th percentile)
排除标准
- •Newborns for whom no urine sample is interpretable
- •Those with a significant clinical-biological anomaly
- •Neonates with hemodynamic disorders such as low blood pressure (median < gestational age) or hypovolemia (shock, signs of dehydration, need for volume expansion) during the first 3 days of life
结局指标
主要结局
Longitudinal changes in urinary creatinine excretion in newborns
时间窗: Longitudinal changes of collected samples from birth until discharge from the maternity hospital (i.e. from birth up to 72 hours postnatal age)
Urine samples will be collected at each diaper change from birth until discharge
次要结局
未报告次要终点
研究者
Jean-Michel HASCOET
Professor
Central Hospital, Nancy, France
