RCT of Headbox Oxygen Vs CPAP for neonatal respiratory distress in non-tertiary hospitals

在新南威尔士州，由于呼吸困难，每年有数百名婴儿从当地综合医院的托儿所转到设有新生儿重症监护病房的医院。通常情况下，母亲在转移时无法陪伴婴儿，从而导致压力。当一位母亲最终被转移时，她经常与她的伴侣和当地的支持人员分开，这进一步加剧了焦虑。此外，如果婴儿必须转移，可能需要侵入性程序来确保安全。目前，在当地医院需要氧气的婴儿被安置在婴儿床里，婴儿的头部周围有一个透明的塑料盒，氧气被输送到盒子里（headbox oxygen）。还有一种提供氧气的替代方法叫做CPAP（持续气道正压通气）。这包括通过柔软的橡胶尖头将氧气直接送入婴儿的鼻子。CPAP自20世纪70年代开始使用。它是澳大利亚和世界上许多新生儿重症监护病房婴儿呼吸支持的主要形式。有证据表明，死亡和肺部疾病可能会减少。然而，这些研究中的婴儿比当地医院托儿所的婴儿病得更重，体型更小。在新西兰的一些地方托儿所使用了CPAP，但是没有研究表明CPAP是否减少了医院间转院的需要。该研究将涉及根据其现场医疗和护理人员水平而选择的医院。这些医院将得到两个使用CPAP作为主要呼吸支持形式的新生儿重症监护病房的支持和建议。需要吸氧的婴儿将被随机分配到头盒吸氧或CPAP。如果婴儿变得如此不舒服，以至于满足某些预设标准，婴儿将以通常的方式转移到新生儿重症监护病房。如果CPAP安全地减少了医院间转院的需要，许多家长将免于与转院相关的焦虑，以及它经常引起的分离。

Each year in NSW hundreds of babies are transferred from local general hospital nurseries to a hospital with Neonatal Intensive Care Unit (NICU) because of breathing difficulties. Frequently, mothers are unable to accompany their babies at the time of transfer, leading to stress. When a mother is eventually transferred she is often separated from her partner and local supports causing further anxiety. In addition, if a baby has to be transferred, invasive procedures may be needed to ensure safety. Currently, babies who need oxygen in a local hospital are placed in a crib with a clear plastic box around their head and oxygen is run into the box (headbox oxygen). There is an alternative method of providing oxygen called CPAP (Continuous Positive Airway Pressure). This involves giving the oxygen directly into the baby's nose via soft rubber prongs. CPAP has been used since the 1970's. It is the main form of respiratory support for infants in many NICUs in Australia and the world. There is some evidence that death and lung disease may be reduced. However, the babies in these studies are sicker and smaller than babies in local hospital nurseries. CPAP is used in some local nurseries in New Zealand, however no studies have been done to see if CPAP reduces the need for inter-hospital transfer. The study will involve hospitals that have been selected because of their level of on site medical and nursing staff. These hospitals will have support and advice from two NICUs that use CPAP as their main form of respiratory support. Babies who need oxygen will be randomly allocated to either have headbox oxygen or CPAP. If the baby becomes so unwell such that certain preset criteria are met, the baby will be transferred to a NICU in the usual way. If CPAP safely reduces the need for inter-hospital transfer, many parents will be saved the anxiety associated with transfer, and the separation it often causes.