Self-directed Video Versus Instructor-based Neonatal Resuscitation Training

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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. Specific aim: To compare the effectiveness of two different teaching strategies on the quality of the ventilation of a mannequin, using a mask by NAÏVE providers. In two different moments, approximately 15 minutes after having taken the course and at a mean of 3 months afterwards. Two different groups of novice providers will be randomly selected to receive one of the following teaching strategies: A. A Video based Self instruction with simultaneous video triggered practice with a mannequin without instructor feedback (Spanish in South America, English in North America) on initial steps and adequate mask ventilation for neonatal resuscitation. B. A pre standardized hands on lesson will be offered by a NRP certified instructor followed by a debriefing session per a pre-validated OSCE protocol (current standard). Afterwards, all the subjects will be invited to ventilate a mannequin with a standardized instruction (tbd for example…2 minutes ventilation, rate 40 to 60 and the necessary pressure to slightly reach chest rising). This performance will be digitally recorded. Two independent certified instructors will evaluate the performance, blinded to the assigned group. A previously validated OSCE (objective structured clinical evaluation) performance evaluation grid will be used. The gold standard will consist on a high quality performance done by an NRP instructor.

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

Conditions
-----------------
Resuscitation of Newborn Training

Intervention / Treatment
-----------------
* Other: Self instructed video learning
* Other: instructor training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: previous experience in NRP

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Self instructed video learning<br>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. | Other: Self instructed video learning<br>* 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.<br>* Other names: Self learning video;|
| Active Comparator: instructor training<br>A standard hands-on training with a face-to-face instructor following a pre-validated OSCE program guidelines. | Other: instructor training<br>* a pre-validated OSCE neonatal resuscitation program<br>* Other names: face to face training in neonatal CPR;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a pre-validated OSCE | proportion of students completing the mandatory fields of the a pre-validated OSCE evaluation grid | approximately 15 minutes after having taken the course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a pre-validated OSCE | proportion of students approving the OSCE tests | approximately 15 minutes after having taken the course | 
| a pre-validated OSCE | proportion of students approving the OSCE tests | at 3 months | 
| Respiratory rate | Respiratory rate provided to the mannequin, number of chest excursions during each performance session. | approximately 15 minutes after having taken the course | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
self instructed resuscitation training