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