磁共振转运培养箱用于新生儿头颅磁共振检查的多中心前瞻性随机对照研究

Application of magnetic resonance imaging-compatible incubator in cranial magnetic resonance imaging for neonates: a multicenter prospective randomized clinical trial

摘要:

目的 评价磁共振（MRI）转运培养箱用于新生儿头颅MRI检查的安全性和有效性。方法 将120例在3家医院住院且需行头颅MRI检查的新生儿随机分为对照组和试验组（n=60）。试验组使用磁共振转运培养箱转运后，于转运培养箱内行头颅MRI检查；对照组使用普通暖箱转运后，在暖箱外行MRI检查。采集患儿主要有效性指标（检查时间）、次要有效性指标（检查次数、首次使用日MRI完成率），安全性指标（不良事件发生率和生命体征情况）进行统计学比较分析。结果 两组患儿MRI检查时间、MRI检查次数及首次使用日MRI完成率比较差异均无统计学意义（P > 0.05）。两组患儿不良事件发生率及检查前后不同时期呼吸频率、心率、血压、血氧饱和度等生命体征比较差异均无统计学意义（P > 0.05）。结论 磁共振转运培养箱的使用未能显著缩短检查时间，但其提供了一个相对稳定的检查环境，且具有可接受的安全性，可在更大样本人群中进一步研究。

Abstract:

Objective To study the safety and efficacy of magnetic resonance imaging (MRI)-compatible incubator in cranial MRI examination for neonates. Methods A total of 120 neonates who were hospitalized in three hospitals and needed to undergo MRI examination were randomly divided into a control group and an experimental group, with 60 neonates in each group. The neonates in the experimental group were transferred with MRI-compatible incubator and underwent cranial MRI examination inside the MRI-compatible incubator, and those in the control group were transferred using a conventional neonatal transfer incubator and then underwent MRI examination outside the incubator. The two groups were compared in terms of the primary efficacy index (total examination time), secondary efficacy indices (times of examination, MRI completion rate on the first day of use), and safety indices (incidence rate of adverse events and vital signs). Results There were no significant differences in total examination time, times of examination, and MRI completion rate on the first day of use between the two groups (P > 0.05). There were also no significant differences between the two groups in the incidence rate of adverse events and vital signs such as respiratory rate, heart rate, blood pressure, and blood oxygen saturation rate at different time points before and after examination (P > 0.05). Conclusions The use of MRI-compatible incubator does not significantly shorten the examination time of cranial MRI, but it does provide a relatively stable environment for examination with acceptable safety. There is a need for further studies with a larger population.