新生儿口腔闭塞的时间:ToSCiN混合方法研究
Nick Lansdale1,2, Kerry Woolfall3, Elizabeth Deja3
1Department of Paediatric and Neonatal Surgery, Royal Manchester Children's Hospital, Manchester, UK.
Health technology assessment (Winchester, England)
|November 2, 2024
概括
在新生儿中进行临床试验早期与晚期口腔闭塞是可行的. 该研究确定了试验设计的挑战和建议,确保在英国有足够的合格婴儿.
科学领域:
- 新生儿手术 新生儿手术
- 临床试验可行性研究
- 胃口管理 胃口管理
背景情况:
- 接受紧急腹部手术的新生儿通常需要口腔,需要第二次手术才能关闭.
- 新生儿口腔闭塞的最佳时间目前尚不清楚,需要通过随机对照试验进行调查.
- 这种试验在设计和执行方面存在重大挑战.
研究的目的:
- 确定进行临床试验的可行性,比较新生儿的早期和晚期口腔闭塞.
- 确定试验实施的潜在挑战和促进者.
- 收集临床医生和家长关于最佳试验参数的见解.
主要方法:
- 采用混合方法方法,包括临床医生调查,前性观察队列研究,家长访谈和重点小组.
- 数据来自英国各地的专业新生儿外科手术中心.
- 对现有的临床数据库进行了分析,以估计符合条件的患者群体.
主要成果:
- 一项对166名专业人员的调查表明,6周是闭口腔最常见的目标,但存在显著的差异.
- 这项前性队列研究招募了56名婴儿,主要是患有死角性肠球炎或肠孔的早产婴儿.
- 临床医生和家长强调,需要在试验手臂中灵活地考虑牙关闭时间,特别是对于极度早产的婴儿.
结论:
- 随机对照试验比较新生儿早期和晚期口腔闭塞是可行的,并被利益相关者认为是重要的.
- 在英国,有足够的合格婴儿支持这样的试验.
- 关键的挑战包括平衡,管理极早产婴儿和后勤问题,这些问题可以通过灵活的试验设计和清晰的沟通来解决.
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