随机试验：对于患有出血后脑室扩张的早产儿，采用引流、灌洗和纤维蛋白溶解治疗的效果：2 年时的发育结果。

Randomized trial of drainage, irrigation and fibrinolytic therapy for premature infants with posthemorrhagic ventricular dilatation: developmental outcome at 2 years.

机构信息

Neonatal Medicine, University of Bristol Medical School, Southmead Hospital, Bristol BS10 5NB, United Kingdom.

出版信息

Pediatrics. 2010 Apr;125(4):e852-8. doi: 10.1542/peds.2009-1960. Epub 2010 Mar 8.

DOI:10.1542/peds.2009-1960

PMID:20211949

Abstract

BACKGROUND

Preterm infants who develop posthemorrhagic ventricular dilatation (PHVD) have a high risk of cognitive and motor disability. No clinical intervention has been proven to reduce neurodevelopmental disability in such infants. We investigated whether drainage, irrigation, and fibrinolytic therapy (DRIFT), which aims to lower pressure, distortion, free iron, and cytokines, reduces death or severe disability in PHVD.

METHODS

We randomly assigned 77 preterm infants with PHVD to either DRIFT or standard treatment (ie tapping off cerebrospinal fluid to control excessive expansion). Severe disability was assessed at 2 years' corrected age and included severe sensorimotor disability and cognitive disability (<55 on the Bayley Mental Development Index).

RESULTS

Of 39 infants assigned to DRIFT, 21 (54%) died or were severely disabled versus 27 of 38 (71%) in the standard group (adjusted odds ratio 0.25 [95% confidence interval: 0.08-0.82]). Among the survivors, 11 of 35 (31%) in the DRIFT group had severe cognitive disability versus 19 of 32 (59%) in the standard group (adjusted odds ratio: 0.17 [95% confidence interval: 0.05-0.57]). Median Mental Development Index was 68 with DRIFT and <50 with standard care. Severe sensorimotor disability was not significantly reduced.

CONCLUSIONS

Despite an increase in secondary intraventricular bleeding, DRIFT reduced severe cognitive disability in survivors and overall death or severe disability.

摘要

背景

患有出血后脑室扩张（PHVD）的早产儿有发生认知和运动功能障碍的高风险。目前尚无临床干预措施被证明可降低此类婴儿的神经发育残疾风险。我们研究了旨在降低压力、变形、游离铁和细胞因子的引流、冲洗和纤维蛋白溶解疗法（DRIFT）是否可降低 PHVD 患儿的死亡或严重残疾发生率。

方法

我们将 77 例 PHVD 早产儿随机分配至 DRIFT 组或标准治疗组（即通过放脑脊液控制过度扩张）。在纠正年龄 2 岁时评估严重残疾，包括严重感觉运动残疾和认知障碍（贝利发育指数 <55）。

结果

在接受 DRIFT 治疗的 39 例婴儿中，21 例（54%）死亡或严重残疾，而标准治疗组的 27 例（71%）（校正比值比 0.25 [95%置信区间：0.08-0.82]）。在幸存者中，DRIFT 组的 11 例（31%）有严重认知障碍，而标准治疗组的 19 例（59%）（校正比值比：0.17 [95%置信区间：0.05-0.57]）。DRIFT 组的平均智力发育指数为 68，而标准治疗组为 <50。严重感觉运动残疾未显著降低。