Self-directed Video Versus Instructor-based Neonatal Resuscitation Training

Resuscitation of Newborn Training Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01847911
• Other study ID #: GCO 13-1336
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: December 12, 2018

Study information

• Verified date: January 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: December 12, 2018
• Est. primary completion date: December 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Resuscitation of Newborn Training

Intervention

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.
• instructor training
a pre-validated OSCE neonatal resuscitation program

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Fisher and Paykel Healthcare, Pontifical Catholic University of Argentina

Countries where clinical trial is conducted

United States,  Argentina,  Chile,  Mexico, 

References & Publications (1)

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 c — View Citation

Outcome

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