跳至主要内容
临床试验/NCT01847911
NCT01847911已完成不适用

Self-directed Video Versus Instructor-based Neonatal Resuscitation Training of Novice Providers. A Controlled Blinded Randomized Non-inferiority Multicenter Study

Icahn School of Medicine at Mount Sinai7 个研究点 分布在 4 个国家目标入组 134 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
134
试验地点
7
主要终点
a pre-validated OSCE

研究概览

简要总结

The effect of a self directed video strategy will be compared to a face to face neonatal resuscitation training program. The hypothesis is that both strategies are equivalent.

详细描述

The NRP is becoming more and more a self learning program followed by a written test and practical hands-on evaluation; but the way the practical skills are taught and practiced has not been uniformly determined.

The current strategies for teaching involve resuscitation instructors. There are several difficulties in the developing world to achieve the objective of having a provider trained in neonatal resuscitation in every delivery. Part of this problem is due to the lack of instructors and-or budget constraint in addition to logistic difficulties.

Our Hypothesis is that a well developed self administered video complemented by a self practice using a mannequin will allow providers to reach at least similar performances on the initial steps and mask ventilation for neonatal resuscitation.

Objectives:

The aim of this study is to test the hypothesis that a self administrated video jointly with a mannequin give similar results than the current Neonatal Resuscitation Program (NRP), a pre-validated Objective Structured Clinical Examination (OSCE)hands-on course provided by a certified instructor.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Medical Students from second year and above not previously trained in NRP (the Neonatal Resuscitation Program)
  • •Nursing Students from second year and above not previously trained in NRP
  • •Informed consent signed

排除标准

  • •previous experience in NRP

研究组 & 干预措施

Self instructed video learning

Experimental

A complete video lesson of neonatal resuscitation including initial resuscitative maneuvers and administration of ventilation with a SIB and a T-piece resuscitator presented in the primary language of the participating center or university (Spanish or English). A portable kit with a newborn mannequin will be provided for independent video guided practice during the session.

干预措施: Self instructed video learning (Other)

instructor training

Active Comparator

A standard hands-on training with a face-to-face instructor following a pre-validated OSCE program guidelines.

干预措施: instructor training (Other)

结局指标

主要结局

a pre-validated OSCE

时间窗: approximately 15 minutes after having taken the course

proportion of students completing the mandatory fields of the a pre-validated OSCE evaluation grid

次要结局

  • a pre-validated OSCE(at 3 months)
  • Respiratory rate(approximately 15 minutes after having taken the course)
  • a pre-validated OSCE(approximately 15 minutes after having taken the course)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edgardo Szyld

Adjunct Professor

Icahn School of Medicine at Mount Sinai

研究点 (7)

Loading locations...

相似试验