跳至主要内容
临床试验/CTRI/2017/07/009104
CTRI/2017/07/009104招募中不适用

Normative values of cerebral blood flow velocities in stable Very Low Birth Weight infants during first month of life

Sir Gangaram Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年7月14日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
To measure Cerebral blood velocities of Anterior cerebral, Middle cerebral and basilar arteries

研究概览

简要总结

Title- Normative values of cerebral blood flow velocities in stable Very Low Birth Weight infants during first month of life.

Very Low Birth Weight (VLBW) infants undergo a dramatic change in hemodynamics during transition in the early neonatal period. Knowledge of postnatal age specific normative data on cerebral blood flow during first few weeks of life might be valuable and may help in early identification of abnormal adaptation. Besides this, cerebral blood flow changes can be detected before clinical decompensation of circulatory response occurs. However before attempting to interpret changes in acute diseased states, it is imperative to understand normal changes in cerebral blood flow in neonates. Longitudinal data on changing cerebral hemodynamics after birth are still lacking. There is a need to define gestation specific longitudinal data on cerebral blood flow indices in hemodynamically stable VLBW infants. We plan to conduct an observational study to determine normative values of cerebral blood flow velocities in anterior cerebral artery, middle cerebral artery and basilar artery in stable VLBW infants in the first month of life (at 2-8 hours, 24 hours, 3 days, 7 days, 14 days and 28 days or at the time of discharge).

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 28.00 Day(s)(—)
性别
All

入选标准

  • All infants less than 1500 gram who are hemodynamically stable, defined as having a resting HR between 120 and 180 per min, SPO2 >85%, CFT <3 sec and mean BP above 10th centile for gestation specific normogram.

排除标准

  • Infants with gross congenital malformations.
  • Infants requiring extensive resuscitation-chest compression or medications at birth.
  • Infants on mechanical ventilation with mean airway pressure (MAP) >12 mbar.
  • Infants requiring inotropes.
  • Infants with intraventricular hemorrhage of Grade II or higher (Papile classification).

结局指标

主要结局

To measure Cerebral blood velocities of Anterior cerebral, Middle cerebral and basilar arteries

时间窗: 2-8 hours of life | 24 hours,3 days,7 days,14 days and 28 days/ or at the time of discharge.

次要结局

未报告次要终点

研究者

发起方
Sir Gangaram Hospital
申办方类型
Research institution and hospital

研究点 (1)

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