NCT01847911

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
4 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
2.5 years until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2018

Completed
Last Updated

February 21, 2021

Status Verified

January 1, 2019

Enrollment Period

3.1 years

First QC Date

April 22, 2013

Last Update Submit

February 18, 2021

Conditions

Resuscitation of Newborn Training

Keywords

self instructed resuscitation training

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • a pre-validated OSCE

    approximately 15 minutes after having taken the course

  • a pre-validated OSCE

    at 3 months

  • Respiratory rate

    approximately 15 minutes after having taken the course

Study Arms (2)

Self instructed video learning

EXPERIMENTAL

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

instructor training

ACTIVE COMPARATOR

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

Other: instructor training

Interventions

Self instructed video learningOTHER

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.

Also known as: Self learning video
Self instructed video learning
instructor trainingOTHER

a pre-validated OSCE neonatal resuscitation program

Also known as: face to face training in neonatal CPR
instructor training

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • previous experience in NRP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

New York University Langone Medical Center

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

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

Oklahoma City, Oklahoma, 73104, United States

Location

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Location

Hospital Italiano

Buenos Aires, City of Buenos Aires, Argentina

Location

Pontificia Universidad Catolica de Chile

Santiago, Chile

Location

Universidad de las Americas Puebla

San Andrés, Cholula, Mexico

Location

Related 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 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.

    PMID: 33589725RESULT

Study Officials

  • Egardo G. Szyld, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

  • Demian Szyld, MD

    New York Simulation Center for the Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Professor

Study Record Dates

First Submitted

April 22, 2013

First Posted

May 7, 2013

Study Start

November 1, 2015

Primary Completion

December 12, 2018

Study Completion

December 12, 2018

Last Updated

February 21, 2021

Record last verified: 2019-01

Locations

US(3)ME(1)CL(1)AR(2)