A Pilot Study to Determine the Feasibility of the Use of Nasal High Flow From Birth in Premature Infants Born at Less Than or Equal to 30 Week Gestational Age.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Need for endotracheal intubation prior to admission to Neonatal Unit
研究概览
简要总结
Recent large studies have shown that not all premature babies need to be intubated (have a breathing tube inserted) and ventilated, nor do they all need to be given lung surfactant routinely. Those studies showed that even very small babies can be safely supported using nasal Continuous Positive Airway Pressure (nCPAP) which is applied tightly to the nose using nasal prongs. This is a type of noninvasive ventilation (NIV) so that the babies continue to breath, albeit with additional support to reduce their work of breathing. However nCPAP has some drawbacks, including that it can cause skin damage to the nose, and that the heating and humidification of the gas is not always sufficient. We have been using, for over 5 years, a different system to support babies after routine intubation. This is another type of noninvasive ventilation called nasal High Flow (nHF) for which we use a Vapotherm Precision Flow device. Published trials show that it is at least as effective as nCPAP to provide NIV and to prevent the subsequent need for intubation and/or surfactant. However nHF is superior to nCPAP in respect it does not cause nose damage and its heating and humidification is excellent. This pilot study aims to describe and evaluate the use of nHF, using a standard commercially available system (Precision Flow, Vapotherm Inc.), from birth, in babies born less than 30 completed weeks gestation, with a view to avoiding intubation and ventilation. This study is important to establish the feasibility of using nHF immediately after birth.
详细描述
We propose to pilot the use of this mobile nHF unit, using the Vapotherm Precision Flow device, in the premature population of babies who would normally be either intubated and given surfactant routinely, or be maintained on nCPAP until arrival on the Neonatal Intensive Care Unit (NICU) then transferred onto nHF. Parents will be informed about the pilot and their permission will be sought. We aim to recruit 40 babies less than 30 weeks gestation.
The reason for undertaking a pilot study of this nature is to establish feasibility and proof of concept. It is not designed to be compared to using nCPAP to stabilise babies immediately after birth (although that will be the next and logical progression if this proves to be a feasible technique).
The hypothesis is that using nHF to stabilise babies immediately after birth will confer the same advantages as using nCPAP to stabilise babies in this way, which has been demonstrated in the worldwide literature. For units such as ours who use nHF in preference to nCPAP, this will be an important step in further defining the management of these babies after birth. There is evidence that nHF is at least as good as nCPAP in preventing intubation and reducing lung disease, and it may also offer additional advantages from humidification and reduction in nasal trauma.
The major challenge for this pilot project will be to identify eligible deliveries in a timely manner to ensure that a suitable member of staff is available to speak to parents and gain consent.
Once a delivery has been identified and the parents have agreed to take part, then the following process will take place to manage the newborn baby.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 24 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parental consent
- •24+0 to 30+0 weeks(agreed dates) gestation born alive
- •Breathing spontaneously at birth or soon after with minimal resuscitation
- •Oxygen saturations >90% by 5 minutes
排除标准
- •No parental consent
- •Born in poor condition and unlikely to survive
- •Needing resuscitation including intubation and/or chest compressions
- •Not breathing and thus needing intubation
- •Oxygen saturations <90% by 5 minutes
- •<24 weeks gestation
- •>30 weeks gestation
结局指标
主要结局
Need for endotracheal intubation prior to admission to Neonatal Unit
时间窗: From birth
Babies who are clinically stable will not require intubation prior to admission to the neonatal unit.
次要结局
- Development of pneumothorax within 24 hours of birth(First 24 hours after birth)
- Requirement for endotracheal intubation and surfactant administration after admission to neonatal unit within 24 hours of birth(First 24 hours after admission to neonatal unit)
- Development of bronchopulmonary dysplasia defined as oxygen requirement at 36 weeks corrected age(Defined at 36 weeks corrected age)