Oxygen-saturation targets and outcomes in extremely preterm infants
Oxygen-saturation targets and outcomes in extremely preterm infants
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DOI：
10.1056/nejmoa023080
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发表时间：
2003-09-04
影响因子：
158.5
通讯作者：
Simpson, JM
中科院分区：
文献类型：
--
作者：
Askie, LM;Henderson-Smart, DJ;Simpson, JM
背景：生理学研究表明，长期需要补充氧气的早产儿可能出现慢性低氧血症，这种低氧血症可能导致生长发育不良。轶事报道和未控制的观察性研究表明，较高的氧饱和度范围可能对生长和发育有益。方法：我们进行了一项多中心、双盲、随机、对照试验，涉及358名妊娠小于30周出生的婴儿，这些婴儿在月经后32周仍依赖于补充氧气。他们被随机分配到目标功能氧饱和度范围：91%至94%（标准饱和度组）或95%至98%（高饱和度组）；这一目标在补充氧治疗期间保持不变。主要结果是12个月矫正时的生长和神经发育指标。结果：在12个月矫正年龄时，两组在体重、体长或头围方面无显著差异。主要发育异常的频率在标准饱和度组和高饱和度组之间也没有显著差异（分别为24%和23%，P=0.85）。高饱和度组有6例肺死亡，标准饱和度组有1例肺死亡（P=0.12）。高饱和度组在随机分组后接受较长时间的供氧(中位数，40天vs. 18天
Background: 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.Methods: 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.Results: 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