BACKGROUNDPhysiological studies hav

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

Results (English) 1:

BACKGROUNDPhysiological 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.METHODSWe 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.RESULTSThere 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.CONCLUSIONSTargeting 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.

Results (English) 3:

背景

生理研究表明慢性低氧血症可能发生在早产儿需要补充氧气长期低氧血症，这可能有助于生长发育不良。轶事报告和不受控制的观测研究表明，较高的氧饱和度范围可能是在生长发育方面有益。

方法

我们进行了一项多中心，双盲，随机，对照试验，涉及358名婴儿出世孕龄小于30周者仍然依赖于氧气在矫正胎龄32周。他们被随机分配到目标功能的血氧饱和度的范围是91到百分之94（标准饱和组）或95到百分之98（高饱和度组）；这个目标是维持吸氧时间。主要成果是生长在矫正年龄12个月神经发育的措施。

结果

有重量，组之间没有显著差异的长度，或头围矫正年龄12个月。主要发育异常的发生率也没有显著之间的标准饱和组和高饱和度的不同（百分之24和百分之23组，分别为，P = 0.85）。有六人由于在高饱和度组肺原因和标准饱和组这样一个死亡（P = 0.12）。高饱和度组氧较长一段时间，随机分组后（中位数，40天与18天；P＜0.001），显著高于对氧气依赖率在36周胎龄，显著高于家庭氧疗的频率。

结论

针对具有较高的氧饱和度范围在极度早产的婴儿谁是依赖于氧气没有赋予意义的成长和发展，导致增加的负担，对健康服务。