Which oxygen saturation level should we use for very premature infants? A randomised controlled trial (BOOST -II UK)

对于早产儿，我们应该使用哪种氧饱和度水平？

• 批准号: G0400415/1
• 负责人: Peter Brocklehurst
• 金额: $ 308.12万
• 依托单位: University of Oxford
• 依托单位国家: 英国
• 项目类别: Research Grant
• 财政年份: 2006
• 资助国家: 英国
• 起止时间: 2006 至 无数据
• 项目状态: 已结题
• 来源: https://gtr.ukri.org/projects?ref=G0400415%2F1
• 关键词: oxygen; saturation; level; should; use

In the UK each year over three thousand babies are born more than 12 weeks premature. Two thirds of these very premature babies now survive, but most grow poorly and many have problems breathing. A quarter have at least one major disability at age two, and many have cerebral palsy. Most of these babies require oxygen therapy for several weeks after birth, but we know that giving babies very high levels of oxygen is toxic to the developing eye which may lead to surgery on the eye in order to try and prevent blindness. We do not know whether very preterm babies should only be given enough oxygen to maintain their levels a little above what it is in if they were still in the womb, or whether we should try and keep the their oxygen levels as high as a baby born at the usual time. If oxygen levels are kept low it is likely to prevent eye damage but it may lead to more deaths and may lead to other disabilities in this group of babies. Alternatively if the oxygen levels are kept high it may cause eye damage but prevent early deaths and other later disability. This randomised study will compare the effects of maintaining the babies oxygen level low (functional arterial oxygen saturations at 85?89%) versus high (functional arterial oxygen saturations at 91?95%) in babies born at less than 28 weeks gestation. The primary outcome for the trial is death and major disability at age 2 years. Secondary outcomes include retinal surgery for retinopathy of prematurity as well as duration of oxygen therapy, chronic lung disease, growth and health service utilisation. The trial will recruit 1,200 babies from 20 UK centres over a period of four years.

在英国，每年有超过3000名婴儿早产超过12周。这些早产儿中有三分之二现在存活了下来，但大多数发育不良，许多人有呼吸问题。四分之一的孩子在两岁时至少有一种主要残疾，许多孩子患有脑瘫。大多数这样的婴儿在出生后几周需要氧气治疗，但我们知道，给婴儿高浓度的氧气对发育中的眼睛是有毒的，这可能导致对眼睛进行手术，以防止失明。我们不知道是否应该只给早产儿提供足够的氧气来维持他们在子宫里时的水平，或者我们是否应该试着让他们的氧气水平和正常时间出生的婴儿一样高。如果氧含量保持在较低水平，可能会防止眼睛受损，但可能会导致更多的死亡，并可能导致这组婴儿出现其他残疾。另外，如果氧含量保持在高水平，可能会造成眼睛损伤，但可以防止早期死亡和其他后来的残疾。这项随机研究将比较维持婴儿低氧水平(功能性动脉氧饱和度为85？89%)与高(功能性动脉血氧饱和度为91？95%)，发生在妊娠少于28周的婴儿身上。试验的主要结局是2岁时死亡和主要残疾。次要结果包括早产儿视网膜病变的视网膜手术，以及氧气治疗的持续时间，慢性肺病，生长和健康服务的利用。这项试验将在四年的时间里从英国20个中心招募1200名婴儿。