Askie Lisa Maree, Henderson-Smart David John, Irwig Les, Simpson Judy Margaret
Centre for Perinatal Health Services Research, University of Sydney, NSW, Australia.
N Engl J Med. 2003 Sep 4;349(10):959-67. doi: 10.1056/NEJMoa023080.
Physiological studies have shown that chronic hypoxemia may occur in preterm infants who require supplemental oxygen for extended periods and that this hypoxemia may contribute to poor growth and development. Anecdotal reports and uncontrolled observational studies have suggested that a higher oxygen-saturation range may be beneficial in terms of growth and development.
We conducted a multicenter, double-blind, randomized, controlled trial involving 358 infants born at less than 30 weeks of gestation who remained dependent on supplemental oxygen at 32 weeks of postmenstrual age. They were randomly assigned to a target functional oxygen-saturation range of either 91 to 94 percent (standard-saturation group) or 95 to 98 percent (high-saturation group); this target was maintained for the duration of supplemental-oxygen therapy. The primary outcomes were growth and neurodevelopmental measures at a corrected age of 12 months.
There were no significant differences between the groups in weight, length, or head circumference at a corrected age of 12 months. The frequency of major developmental abnormalities also did not differ significantly between the standard-saturation group and the high-saturation group (24 percent and 23 percent, respectively, P=0.85). There were six deaths due to pulmonary causes in the high-saturation group and one such death in the standard-saturation group (P=0.12). The high-saturation group received oxygen for a longer period after randomization (median, 40 days vs. 18 days; P<0.001) and had a significantly higher rate of dependence on supplemental oxygen at 36 weeks of postmenstrual age and a significantly higher frequency of home-based oxygen therapy.
Targeting a higher oxygen-saturation range in extremely preterm infants who were dependent on supplemental oxygen conferred no significant benefit with respect to growth and development and resulted in an increased burden on health services.
生理学研究表明，长期需要补充氧气的早产儿可能会出现慢性低氧血症，且这种低氧血症可能导致生长发育不良。轶事报道和非对照观察性研究表明，较高的氧饱和度范围可能对生长发育有益。
我们进行了一项多中心、双盲、随机对照试验，纳入了358名孕龄小于30周、在孕龄32周时仍依赖补充氧气的婴儿。他们被随机分配到目标功能氧饱和度范围为91%至94%（标准饱和度组）或95%至98%（高饱和度组）；在补充氧气治疗期间维持该目标。主要结局是校正年龄为12个月时的生长和神经发育指标。
校正年龄为12个月时，两组在体重、身长或头围方面无显著差异。标准饱和度组和高饱和度组主要发育异常的发生率也无显著差异（分别为24%和23%，P=0.85）。高饱和度组有6例因肺部原因死亡，标准饱和度组有1例（P=0.12）。高饱和度组在随机分组后吸氧时间更长（中位数，40天对18天；P<0.001），在孕龄36周时对补充氧气的依赖率显著更高，家庭氧疗频率也显著更高。
对于依赖补充氧气的极早产儿，将氧饱和度目标范围设定得更高在生长发育方面没有显著益处，反而增加了卫生服务负担。
