Department of Neonatology and Brain Center Rudolf Magnus, Wilhelmina Children's Hospital, University Medical Center Utrecht, Utrecht, The Netherlands.
Department of Neonatology, Amalia Children's Hospital, Radboud University Medical Center, Nijmegen, The Netherlands.
Arch Dis Child Fetal Neonatal Ed. 2019 Jan;104(1):F70-F75. doi: 10.1136/archdischild-2017-314206. Epub 2018 Feb 10.
To compare a low versus a higher threshold for intervention in preterm infants with posthaemorrhagic ventricular dilatation.
Multicentre randomised controlled trial (ISRCTN43171322).
14 neonatal intensive care units in six countries.
126 preterm infants ≤34 weeks gestation with ventricular dilatation after grade III-IV haemorrhage were randomised to low threshold (LT) (ventricular index (VI) >p97 and anterior horn width (AHW) >6 mm) or higher threshold (HT) (VI>p97+4 mm and AHW >10 mm).
Cerebrospinal fluid tapping by lumbar punctures (LPs) (max 3), followed by taps from a ventricular reservoir, to reduce VI, and eventually a ventriculoperitoneal (VP) shunt if stabilisation of the VI below the p97+4 mm did not occur.
VP shunt or death.
19 of 64 (30%) LT infants and 23 of 62 (37%) HT infants were shunted or died (P=0.45). A VP shunt was inserted in 12/64 (19%) in the LT and 14/62 (23%) infants in the HT group. 7/12 (58%) LT infants and 1/14 (7%) HT infants required shunt revision (P<0.01). 62 of 64 (97%) LT infants and 36 of 62 (58%) HT infants had LPs (P<0.001). Reservoirs were inserted in 40 of 64 (62%) LT infants and 27 of 62 (43%) HT infants (P<0.05).
There was no significant difference in the primary composite outcome of VP shunt placement or death in infants with posthaemorrhagic ventricular dilatation who were treated at a lower versus a higher threshold for intervention. Infants treated at the lower threshold received more invasive procedures. Assessment of neurodevelopmental outcomes will provide further important information in assessing the risks and benefits of the two treatment approaches.
比较低干预阈值与高干预阈值在伴有出血后脑室扩张的早产儿中的应用效果。
多中心随机对照试验（ISRCTN43171322）。
六个国家的 14 个新生儿重症监护病房。
126 名胎龄≤34 周的伴有 III-IV 级出血后脑室扩张的早产儿，随机分为低阈值组（LT）（脑室指数（VI）＞p97 和前角宽度（AHW）＞6mm）或高阈值组（HT）（VI＞p97+4mm 和 AHW＞10mm）。
腰椎穿刺（LP）行脑积液引流（最多 3 次），然后通过脑室内储液囊引流，以降低 VI，若 VI 稳定在 p97+4mm 以下，则最终行脑室-腹腔（VP）分流术。
VP 分流或死亡。
LT 组 64 例中有 19 例（30%）、HT 组 62 例中有 23 例（37%）行 VP 分流或死亡（P=0.45）。LT 组 12 例（19%）、HT 组 14 例（23%）行 VP 分流术。LT 组 12 例中有 7 例（58%）、HT 组 14 例中有 1 例（7%）需行分流管调整术（P＜0.01）。LT 组 64 例中有 62 例（97%）、HT 组 62 例中有 36 例（58%）行 LP（P＜0.001）。LT 组 64 例中有 40 例（62%）、HT 组 62 例中有 27 例（43%）行脑室内储液囊植入术（P＜0.05）。
对于出血后脑室扩张的早产儿，采用低干预阈值与高干预阈值治疗，VP 分流术或死亡的主要复合结局无显著差异。采用低干预阈值治疗的婴儿接受了更多的有创性操作。评估神经发育结局将为评估两种治疗方法的风险和获益提供进一步的重要信息。
