跳至主要内容
临床试验/NCT05813730
NCT05813730招募中不适用

Definition of Urinary Creatinine Excretion Time in the Neonatal Period, in Full Term Newborns : a Prospective Monocentric Study

Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月30日最近更新:
适应症

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

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

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jean-Michel HASCOET

Professor

Central Hospital, Nancy, France

研究点 (2)

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