Objective To determine whether restricting the use of inotrope after diagnosis of low blood pressure (BP) in the first 72 hours of life affects survival without significant brain injury at 36 weeks of postmenstrual age (PMA) in infants born before 28 weeks of gestation. Design Double-blind, placebo-controlled randomised trial. Caregivers were masked to group assignment. Setting 10 sites across Europe and Canada. Participants Infants born before 28 weeks of gestation were eligible if they had an invasive mean BP less than their gestational age that persisted for ≥15 min in the first 72 hours of life and a cerebral ultrasound free of significant (≥ grade 3) intraventricular haemorrhage. Intervention Participants were randomly assigned to saline bolus followed by either a dopamine infusion (standard management) or placebo (5% dextrose) infusion (restrictive management). Primary outcome Survival to 36 weeks of PMA without severe brain injury. Results The trial terminated early due to significant enrolment issues (7.7% of planned recruitment). 58 infants were enrolled between February 2015 and September 2017. The two groups were well matched for baseline variables. In the standard group, 18/29 (62%) achieved the primary outcome compared with 20/29 (69%) in the restrictive group (p=0.58). Additional treatments for low BP were used less frequently in the standard arm (11/29 (38%) vs 19/29 (66%), p=0.038). Conclusion Though this study lacked power, we did not detect major differences in clinical outcomes between standard or restrictive approach to treatment. These results will inform future studies in this area. Trial registration number [NCT01482559][1], EudraCT 2010-023988-17. Data may be obtained from a third party and are not publicly available. It is currently not possible to share the HIP Trial data set. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01482559&atom=%2Ffetalneonatal%2F106%2F4%2F398.atom

中文翻译：

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早产儿低血压 (HIP) 随机试验

目的 确定在出生后最初 72 小时诊断为低血压 (BP) 后限制正性肌力药的使用是否会影响妊娠 28 周前出生的婴儿在 36 周后无明显脑损伤的情况下的存活率。设计双盲、安慰剂对照的随机试验。看护者对小组分配不知情。在欧洲和加拿大设置 10 个站点。参与者 妊娠 28 周前出生的婴儿符合条件，条件是他们的侵入性平均血压低于其胎龄，并且在出生后的前 72 小时内持续≥15 分钟，并且脑超声检查未发现明显（≥ 3 级）脑室内出血。干预参与者被随机分配到生理盐水推注组，然后是多巴胺输注（标准管理）或安慰剂（5% 葡萄糖）输注（限制性管理）。主要结果 在没有严重脑损伤的情况下存活至 PMA 36 周。结果 由于严重的招募问题（占计划招募的 7.7%），试验提前终止。2015 年 2 月至 2017 年 9 月期间招募了 58 名婴儿。两组的基线变量匹配良好。在标准组中，18/29 (62%) 达到了主要结果，而在限制性组中为 20/29 (69%) (p=0.58)。标准组中低血压的额外治疗使用频率较低（11/29 (38%) 对 19/29 (66%)，p=0.038）。结论 虽然这项研究缺乏效力，我们没有发现标准或限制性治疗方法在临床结果上存在重大差异。这些结果将为该领域的未来研究提供信息。试用注册号[NCT01482559][1]，EudraCT 2010-023988-17。数据可能从第三方获得，并且不公开。目前无法共享 HIP 试验数据集。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01482559&atom=%2Ffetalneonatal%2F106%2F4%2F398.atom