The Influence of Cut-umbilical Cord Milking (C-UCM) on the Cerebral Oxygenation and Perfusion of Preterm and Term Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Cerebral blood volume
研究概览
简要总结
In this randomized controlled Pilot study the effects of cut-umbilical cord milking on cerebral oxygenation and perfusion measured via near-infrared spectroscopy (NIRS) and the effects on stroke volume (SV) and cardiac output (CO) also measured non-invasively in term and preterm infants are evaluated for the first 15 minutes after birth and compared to a control group.
详细描述
Background
The transition to life after birth is a complex physiological process where the neonate has to establish sufficient ventilation and changes from intra-uterine circulation to extra-uterine circulation take place. During these processes the neonate has to provide the brain with adequate perfusion and oxygen delivery to maintain normal cerebral tissue oxygenation and activity. Instability of cerebral perfusion and oxygenation may be associated with brain damage in preterm infants. The concept of C-UCM may substitute the adverse effects of immediate cord clamping by supplying additional placental blood to the infant, which is mostly performed during caesarean section or in the critically ill neonate.
In this randomized controlled Pilot study the effects of cut-umbilical cord milking on cerebral oxygenation and perfusion measured via near-infrared spectroscopy (NIRS) and the effects on stroke volume (SV) and cardiac output (CO) also measured non-invasively in term and preterm infants are evaluated for the first 15 minutes after birth and compared to a control group.
Aim
The aim of the study is to analyse whether C-UCM in preterm and term infants results in an improvement of cerebral oxygenation and perfusion during immediate neonatal transition measured with NIRS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 1 Minute 至 15 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Neonates with a gestational age ≥28 weeks
- •Delivered by caesarean section
- •Decision to conduct full life support
- •Written informed consent prior to birth
排除标准
- •Neonates with a gestational age <28 weeks
- •No decision to conduct full life support
- •No written informed consent
- •Severe congenital malformations
结局指标
主要结局
Cerebral blood volume
时间窗: within the first 15 minutes after birth.
Changes in CBV (ml/100g brain)
次要结局
- Stroke volume(within the first 15 minutes after birth)
- Cardiac output(within the first 15 minutes after birth)
- Cerebral tissue oxygenation index(within the first 15 minutes after birth)
- Peripheral oxygen saturation(within the first 15 minutes after birth)
- Mean arterial blood pressure(within the first 15 minutes after birth)
- Heart rate(within the first 15 minutes after birth)