Effects of Sustained Inflation or Positive Pressure Ventilation on Release of Adrenomedullin in Preterm Infants With Respiratory Failure at Birth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- AM levels in plasma and urine in preterm infants with respiratory failure
研究概览
简要总结
In this clinical trial the Investigators aimed to assess the Adrenomedullin (AM) release in urine and plasma in preterm infants undergoing Sustained Inflation or Positive Pressure Ventilation at birth to manage respiratory failure.
详细描述
Background and objectives: The respiratory management in the DR may play an important role in the development and prevention of lung injury. The sustained lung inflation (SI) is a promising approach to facilitate cardio-respiratory transition, but currently, although it has been shown to decrease the duration of MV, seems not to guarantee relevant benefits compared to Positive Pressure Ventilation (PPV). In order to clarify the impact of these two different approaches on lung tissues, this study measures Adrenomedullin (AM), which is a biomarker involved in lung development.
Methods: we conducted a prospective case control-study in a cohort of very low birth weight (VLBW) infants (< 1500 g) of 28+0-30+6 weeks of gestational age (GA), who received SI or PPV during stabilization in DR.
Exclusion criteria were major malformations (i.e. congenital heart disease, cerebral, lung and abdominal malformations), fetal hydrops, lack of parental consent and need for endotracheal intubation at birth.
Blood samples for AM measurement were collected at birth from the arterial umbilical cord before resuscitation maneuvers, then at 1 hour from birth and at 24 hours from birth. Moreover, urine samples were collected, in correspondence with the first urine emission while in NICU and at 24 hours of life.
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
- None
入排标准
- 年龄范围
- 28 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •gestational age between 28+0 and 30+6
- •need for respiratory support in the delivery room
排除标准
- •major malformations (i.e. congenital heart disease, cerebral, lung and abdominal malformations)
- •fetal hydrops
- •lack of parental consent.
- •Need for endotracheal intubation at birth
研究组 & 干预措施
Positive Pressure Ventilation
Positive Pressure Ventilation ( peak pressure set at 25 cmH20 and PEEP set at 5 cmH2O, with 40 inflations per minute)
干预措施: Positive Pressure Ventilation (Procedure)
Sustained Inflation
Prolonged inflation ( 25 cmH20 for 15 seconds) followed by PEEP set at 5 cmH2O
干预措施: Sustained Inflation (Procedure)
结局指标
主要结局
AM levels in plasma and urine in preterm infants with respiratory failure
时间窗: 24 hours
to investigate, in a cohort of preterm infants with respiratory failure at birth, the short-term AM release (plasma and urine samples at different time-points) after initial resuscitation with SI or PPV.
次要结局
未报告次要终点