Outcome of children in the indomethacin intraventricular hemorrhage prevention trial
Outcome of children in the indomethacin intraventricular hemorrhage prevention trial
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DOI：
10.1542/peds.105.3.485
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发表时间：
2000-03-01
期刊：
影响因子：
8
通讯作者：
Makuch, RW
中科院分区：
文献类型：
--
作者：
Ment, LR;Vohr, B;Makuch, RW
背景。对于早产儿，脑室内出血（IVH）可能与不良的神经发育结果有关。我们已经证明，早期低剂量吲哚美辛治疗与极低出生体重早产儿IVH的发生率和严重程度的降低有关。此外，我们假设早期给药低剂量的吲哚美辛与研究儿童4.5岁时神经发育障碍发生率的增加无关。为了验证这一假设，我们对384名多中心随机吲哚美辛IVH预防试验的极低出生体重幸存者进行了神经发育随访。337名儿童（88%）在54月龄时接受了神经发育检查，包括韦氏学前和小学智力量表修订（WPPSI-R）、皮博迪图片词汇测试修订（ppvd - r）和标准神经学检查。在337名参与研究的儿童中，170名儿童随机接受早期低剂量吲哚美辛治疗，167名儿童接受安慰剂治疗。接受神经系统检查的165名使用吲哚美辛的儿童中有12名（7%）和158名使用安慰剂的儿童中有11名（7%）被发现患有脑瘫。对于接受认知结果数据的233名英语单语儿童，接受吲哚美辛治疗的儿童的平均胎龄明显低于接受安慰剂治疗的儿童。此外，虽然WPPSI-R或PPVT-R评分在两组之间没有差异，但根据功能范围对WPPSI-R全量表智商的分析表明，随机分配到早期低剂量吲哚美辛组的儿童智力发育迟缓明显减少（在吲哚美辛研究儿童中，9%的儿童智商为80，而安慰剂组为17%）。通过PPVT-R评估，与安慰剂儿童相比，吲哚美辛儿童在词汇技能方面的困难也明显减轻。这些数据表明，对于早产儿，早期给予低剂量吲哚美辛治疗与54个月矫正年龄时不良神经发育功能无关。
Background. For preterm infants, intraventricular hemorrhage (IVH) may be associated with adverse neurodevelopmental outcome. We have demonstrated that early low-dose indomethacin treatment is associated with a decrease in both the incidence and severity of IVH in very low birth weight preterm infants. In addition, we hypothesized that the early administration of low-dose indomethacin would not be associated with an increase in the incidence of neurodevelopmental handicap at 4.5 years of age in our study children.Methods. To test this hypothesis, we provided neurodevelopmental follow-up for the 384 very low birth weight survivors of the Multicenter Randomized Indomethacin IVH Prevention Trial. Three hundred thirty-seven children (88%) were evaluated at 54 months' corrected age, and underwent neurodevelopmental examinations, including the Wechsler Preschool and Primary Scale of Intelligence-Revised (WPPSI-R), the Peabody Picture Vocabulary Test-Revised (PPVT-R), and standard neurologic examinations.Results. Of the 337 study children, 170 had been randomized to early low-dose indomethacin therapy and 167 children had received placebo. Twelve (7%) of the 165 indomethacin children and 11 (7%) of the 158 placebo children who underwent neurologic examinations were found to have cerebral palsy. For the 233 English-monolingual children for whom cognitive outcome data follow, the mean gestational age was significantly younger for the children who received indomethacin than for those who received placebo. In addition, although there were no differences in the WPPSI-R or the PPVT-R scores between the 2 groups, analysis of the WPPSI-R full-scale IQ by function range demonstrated significantly less mental retardation among those children randomized to early low-dose indomethacin (for the indomethacin study children, 9% had an IQ 80, compared with the placebo group, for whom 17% had an IQ 80). Indomethacin children also experienced significantly less difficulty with vocabulary skills as assessed by the PPVT-R when compared with placebo children.Conclusions. These data suggest that, for preterm neonates, the early administration of low-dose indomethacin therapy is not associated with adverse neurodevelopmental function at 54 months' corrected age.