"Improves Physiological Based Cord Clamping (PBCC) the Systemic and Cerebral Oxygenation in Term Infants?"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- Change in cerebral regional oxygen saturation (crSO2)
研究概览
简要总结
The first major intervention a newborn infant is facing following birth is clamping of the umbilical cord. This means separation of the infant from the placenta, the newborn becomes an independent individual, especially from a cardio-circulatory perspective. There is still a lack of understanding of the issues associated with umbilical cord clamping. The aim of the present study is to investigate whether cord clamping after onset of sufficient spontenous breathing is able to improve systemic and cerebral oxygenation in term infants delivered vaginally.
详细描述
Recent literature focused very much on the appropriate timing of the cord clamping (CC), distinguishing immediate cord clamping (ICC) from delayed cord clamping (DCC). Although potential benefits for DCC have been documented, especially for preterm infants, ICC still is the most widely used procedure. Although the reasons for this are unclear, a lack of understanding of the issues associated with umbilical cord clamping is thought to be a major underlying factor.
In animal research with fetal lambs it has been shown, that aeration of the lung played a crucial role in undisturbed cardio-circulatory immediate neonatal transition. Thus a new concept of DCC was introduced, delaying cord clamping until ventilation/aeration of the lung was established, calling this "Physiological-Based Cord Clamping" (PBCC). It was shown, that PBCC improved not only cardiovascular function in preterm lambs, but systemic and cerebral oxygenation too. Systemic oxygenation was measured using pulseoximetry, and cerebral oxygenation was measured using near infrared spectroscopy (NIRS).
Until now, human data for PBCC are lacking. Therefore, the aim of the present study is to investigate whether PBCC is able to improve systemic and cerebral oxygenation in term infants delivered vaginally.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 0 Minutes 至 30 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Vaginally born and term infants
- •undisturbed transition period
排除标准
- •congenital malformations
- •respiratory support during transition period
结局指标
主要结局
Change in cerebral regional oxygen saturation (crSO2)
时间窗: 15 minutes
Difference in the course of postnatal increase of crSO2 (%). crSO2 is measured with nearinfrared spectroscopy (NIRS). Immediately after delivery, the NIRS sensor is placed on the left forehead, measuring crSO2 non-invasively over the observational period.
次要结局
- Change in peripheral arterial oxygen saturation (SpO2)(15 minutes)
- Change in Cerebral blood volume (CBV)(15 minutes)
- Evaluation of cardiac shunt parameters(20 minutes)
- Evaluation of preload parameters(20 minutes)
- right atrial (RA) and right ventricular (RV) dimension parameters(20 minutes)
- right ventricular (RV) systolic function(20 minutes)
研究者
Schwaberger Bernhard, MD PhD
Ass.Dr. (MD) Mirjam Pocivalnik
Medical University of Graz