Self-directed Video Versus Instructor-based Neonatal Resuscitation Training

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

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.

Study Overview

• Status: Completed
• Conditions: Resuscitation of Newborn Training
• Intervention / Treatment: Other: Self instructed video learning; Other: instructor training

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.

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires
    • Pilar, Buenos Aires, Argentina
      • Hospital Universitario Austral
  • City Of Buenos Aires
    • Buenos Aires, City Of Buenos Aires, Argentina
      • Hospital Italiano
• Chile
  • Santiago de Chile, Chile
    • Pontificia Universidad Catolica de Chile
• Mexico
  • Cholula
    • San Andres, Cholula, Mexico
      • Universidad de las Americas Puebla
• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai
    • New York, New York, United States, 10016
      • New York University Langone Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma, Department of Pediatrics, Neonatal-Perinatal Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Collaborators: Fisher and Paykel Healthcare; Pontifical Catholic University of Argentina
• Investigators: Principal Investigator: Egardo G. Szyld, MD, Icahn School of Medicine at Mount Sinai; Principal Investigator: Demian Szyld, MD, New York Simulation Center for the Health Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): December 12, 2018
• Study Completion (Actual): December 12, 2018

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: May 2, 2013
• First Posted (Estimate): May 7, 2013

Study Record Updates

• Last Update Posted (Actual): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: self instructed resuscitation training
• Other Study ID Numbers: GCO 13-1336