Self-directed Video Versus Instructor-based Neonatal Resuscitation Training

NCT ID: NCT01847911

Last Updated: 2021-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2018-12-12

Brief Summary

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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

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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.

Conditions

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Resuscitation of Newborn Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Self instructed video learning

Intervention Type OTHER

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

Group Type ACTIVE_COMPARATOR

instructor training

Intervention Type OTHER

a pre-validated OSCE neonatal resuscitation program

Interventions

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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.

Intervention Type OTHER

instructor training

a pre-validated OSCE neonatal resuscitation program

Intervention Type OTHER

Other Intervention Names

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Self learning video face to face training in neonatal CPR

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Pontifical Catholic University of Argentina

OTHER

Sponsor Role collaborator

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Edgardo Szyld

Adjunct Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Egardo G. Szyld, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Demian Szyld, MD

Role: PRINCIPAL_INVESTIGATOR

New York Simulation Center for the Health Sciences

Locations

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New York University Langone Medical Center

New York, New York, United States

Site Status

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status

University of Oklahoma, Department of Pediatrics, Neonatal-Perinatal Medicine

Oklahoma City, Oklahoma, United States

Site Status

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Site Status

Hospital Italiano

Buenos Aires, City of Buenos Aires, Argentina

Site Status

Pontificia Universidad Catolica de Chile

Santiago, , Chile

Site Status

Universidad de las Americas Puebla

San Andrés, Cholula, Mexico

Site Status

Countries

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United States Argentina Chile Mexico

References

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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.

Reference Type RESULT
PMID: 33589725 (View on PubMed)

Other Identifiers

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GCO 13-1336

Identifier Type: -

Identifier Source: org_study_id

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