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临床试验/CTRI/2017/09/009653
CTRI/2017/09/009653尚未招募不适用

Normative values of hemodynamic parameters in stable VLBW neonates during first month of life

Manoj Modi1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年9月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
Manoj Modi
入组人数
300
试验地点
1
主要终点
-BP measurement during first month of life

研究概览

简要总结

The objective of this study is to evaluate gestation specific normative data of non-invasive BP and PI inhemodynamically stable VLBW neonates at day during first month of life.

Allneonates will be enrolled at time of admission to NICU. Demographic characteristicsand antenatal details of enrolled infants, including maternal hypertension,fetal growth restriction, umbilical artery Doppler abnormality, chorioamnitis,antenatal steroid cover, and mode of delivery will be recorded on a proforma.Assessment of vital parameters will be made once in a day by single researchnurse, daily during first week, and weekly thereafter till discharge.  At each assessment, heart rate, oxygensaturation (SPO2), capillary refill time (CRT), BP, pulse volume, perfusionindex (PI) and central and peripheral temperature will be recorded.

Sinceinformation on gestation specific longitudinal data is not available in thepublished literature, we are planning to enroll at least 30neonates in each gestation category. Data will be presented as mean (SD) or median (IQR)as per distribution of data.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 30.00 Day(s)(—)
性别
All

入选标准

  • stable very low birth weight neonates.

排除标准

  • Perinatal asphyxia defined as 5 min APGAR <3
  • Neonates on mechanical ventilation with mean airway pressure (MAP) >15 mbar
  • Neonates with congenital heart disease
  • Neonates with hemodynamically significant patent ductus atreriosus (PDA): Duct size >1.5 mm with unrestricted laminar flow plus any one of following: turbulence in MPA, diastolic reversal in post ductal aorta, LA/Ao ratio >1.5
  • Neonates with a diagnosis of persistent pulmonary hypertension (PPHN)
  • Neonates with gross congenital malformations.

结局指标

主要结局

-BP measurement during first month of life

时间窗: day of life 1, 2, 3, 4, 5, 6, 7, 14, 21, 28

次要结局

  • Perfusion Index(Day 1, 3, 7, 14, 28)

研究者

发起方
Manoj Modi
申办方类型
Other [self]

研究点 (1)

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