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临床试验/NCT02967562
NCT02967562已完成不适用

Comparison of a Sustained Inflation to Shorter Inflation Breaths During Resuscitation at Delivery of Prematurely Born Infants

King's College London2 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
63
试验地点
2
主要终点
Expiratory Tidal Volume

研究概览

简要总结

This study compares a fifteen second sustained inflation (SI) to five repeated two - three second 'inflation breaths' during resuscitation at delivery of infants born prematurely.

详细描述

Around 10% of newborns will require some form of assistance after delivery, with babies born more prematurely more likely to require resuscitation

Current UK guidelines advise initial resuscitation with the delivery of five 'inflation breaths' lasting 2-3 seconds with peak inflation pressure of 30cmH2O (20-25cm H2O in premature neonates). Previous studies have shown that despite resuscitation training, clinicians in both simulated and real resuscitation scenarios do not deliver the recommended duration of inflation breaths. This, combined with leaks around the facemask often being as large as 50% or greater, contributes to low expired tidal volumes during resuscitation, thus increasing the likelihood of hypoxia and delay in establishing effective respiration.

The use of sustained inflations (up to 15 seconds), rather than intermittent shorter inflation breaths, has shown promising results, with reduction in the need for intubation, and the need for and duration of mechanical ventilation. Around 30% of units in Germany use sustained inflations as first line delivery room management, as do many other hospitals around the world. Resuscitation guidelines from the USA, UK and Europe suggest that sustained inflations should be researched further.

Several studies have shown that for several lengths of inflation breaths, the expired tidal volume achieved is higher if the baby makes respiratory effort during the inflation (active inflation) and that stimulation of spontaneous respiratory effort is a key part in establishing an FRC, enabling spontaneous breathing, and increasing the likelihood of successful resuscitation.

To date, there are no studies directly comparing whether prolonged inflations are more successful at provoking an inspiration than other methods of resuscitation. We therefore aim to compare a 15 second sustained inflation to repeated shorter inflations to determine which is more effective.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
0 Minutes 至 1 Hour(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born at less than 34 weeks gestation requiring resuscitation at delivery

排除标准

  • Major congenital abnormalities
  • Parents have previously expressed lack of consent for study

结局指标

主要结局

Expiratory Tidal Volume

时间窗: one minute

Expiratory tidal volume during the first minute of resuscitation

次要结局

  • End Tidal Carbon Dioxide Level(10 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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