Clinical trial NCT01847911: Self-directed Video Versus Instructor-based Neonatal Resuscitation Training
Official title: Self-directed Video Versus Instructor-based Neonatal Resuscitation Training of Novice Providers. A Controlled Blinded Randomized Non-inferiority Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resuscitation of Newborn Training
Keywords: self instructed resuscitation training
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: Pontifical Catholic University of Argentina
name: Fisher and Paykel Healthcare
First posted: 2013-05-07
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: a pre-validated OSCE
timeFrame: approximately 15 minutes after having taken the course
Secondary outcomes:
measure: a pre-validated OSCE
timeFrame: approximately 15 minutes after having taken the course
measure: a pre-validated OSCE
timeFrame: at 3 months
measure: Respiratory rate
timeFrame: approximately 15 minutes after having taken the course
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
city: Oklahoma City
country: United States
facility: University of Oklahoma, Department of Pediatrics, Neonatal-Perinatal Medicine
state: Oklahoma
city: Pilar
country: Argentina
facility: Hospital Universitario Austral
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Italiano
state: City Of Buenos Aires
city: Santiago de Chile
country: Chile
facility: Pontificia Universidad Catolica de Chile
city: San Andres
country: Mexico
facility: Universidad de las Americas Puebla
state: Cholula
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Egardo G. Szyld, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: New York Simulation Center for the Health Sciences
name: Demian Szyld, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szyld EG, Aguilar A, Lloret SP, Pardo A, Fabres J, Castro A, Dannaway D, Desai PV, Capelli C, Song CH, Enriquez D, Szyld D; EdM on behalf of the SAVER Study Group. Self-directed video versus instructor-based neonatal resuscitation training: a randomized controlled blinded non-inferiority multicenter international study. J Perinatol. 2021 Jul;41(7):1583-1589. doi: 10.1038/s41372-021-00941-x. Epub 2021 Feb 15.