Early Plasma Protein Levels and Neonatal Hemodynamics: a Prospective Evaluation in Very Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 125
- 试验地点
- 2
- 主要终点
- Evidence of clinical hemodynamic disturbances defined by arterial hypotension (non-invasive measure of MAP - mmHg - pathological for gestational age) or measured at organ colour doppler, echocardiography or NIRS
研究概览
简要总结
The primary aim of this study is to investigate the relationship between early plasma protein levels and hemodynamics in very preterm infants during postnatal transition. Secondary aims are the following: i) to evaluate maternal and neonatal factors affecting plasma protein level at birth; ii) to evaluate the relationship between plasma protein level and albumin level on the first day of life; iii) to evaluate the association between early hypoproteinemia and neonatal mortality and morbidity in very preterm infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Minute 至 1 Hour（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents written informed consent
- •Birth at less than 32 weeks of gestational age
- •Birth in a III level delivery facility at Reunion Island
排除标准
- •Major congenital abnormalities
结局指标
主要结局
Evidence of clinical hemodynamic disturbances defined by arterial hypotension (non-invasive measure of MAP - mmHg - pathological for gestational age) or measured at organ colour doppler, echocardiography or NIRS
时间窗: about 6 hours after birth
次要结局
- Mortality rate(patients will be followed for the duration of hospital stay, that is an average of 8 weeks)
- plasma protein(at 1 second after birth (cord blood sample))
- Albumin level(At 12 hours after birth)