Self-directed Video Versus Instructor-based Neonatal Resuscitation Training
NCT ID: NCT01847911
Last Updated: 2021-02-21
Study Results
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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COMPLETED
NA
134 participants
INTERVENTIONAL
2015-11-30
2018-12-12
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
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.
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 standard hands-on training with a face-to-face instructor following a pre-validated OSCE program guidelines.
instructor training
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.
instructor training
a pre-validated OSCE neonatal resuscitation program
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Nursing Students from second year and above not previously trained in NRP
* Informed consent signed
Exclusion Criteria
18 Years
70 Years
ALL
Yes
Sponsors
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Pontifical Catholic University of Argentina
OTHER
Fisher and Paykel Healthcare
INDUSTRY
Icahn School of Medicine at Mount Sinai
OTHER
Responsible Party
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Edgardo Szyld
Adjunct Professor
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
Icahn School of Medicine at Mount Sinai
New York, New York, United States
University of Oklahoma, Department of Pediatrics, Neonatal-Perinatal Medicine
Oklahoma City, Oklahoma, United States
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina
Hospital Italiano
Buenos Aires, City of Buenos Aires, Argentina
Pontificia Universidad Catolica de Chile
Santiago, , Chile
Universidad de las Americas Puebla
San Andrés, Cholula, Mexico
Countries
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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.
Other Identifiers
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GCO 13-1336
Identifier Type: -
Identifier Source: org_study_id
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