Resuscitation of Newborn TrainingNCT01847911
Self-directed Video Versus Instructor-based Neonatal Resuscitation Training
A study testing Self instructed video learning and instructor training in people with Resuscitation of Newborn Training, run by Icahn School of Medicine at Mount Sinai at 7 sites in 4 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Resuscitation of Newborn Training
- What is being tested?
- Self instructed video learning and instructor training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 7 sitesin 4 countries
- Study dates
- Nov 2015to 12 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- previous experience in NRP
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
United States3 sites
New York University Langone Medical Center
New York, New York, 10016
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
University of Oklahoma, Department of Pediatrics, Neonatal-Perinatal Medicine
Oklahoma City, Oklahoma, 73104
Argentina2 sites
Hospital Italiano
Buenos Aires, City of Buenos Aires
Hospital Universitario Austral
Pilar, Buenos Aires
About this study
Official title: 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.
Read the 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 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.
- 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
- Resuscitation of Newborn Training
- Being tested
- Self instructed video learning, instructor training
- Keywords
- self instructed resuscitation training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self instructed video learningOther
Also called Self learning video
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 trainingOther
Also called face to face training in neonatal CPR
a pre-validated OSCE neonatal resuscitation program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: instructor training |
What is being measured
The primary outcome is the main question the study is designed to answer.
a pre-validated OSCE
proportion of students completing the mandatory fields of the a pre-validated OSCE evaluation grid
Measured: approximately 15 minutes after having taken the course
Secondary outcomes (3)
a pre-validated OSCE
proportion of students approving the OSCE tests
Measured: approximately 15 minutes after having taken the course
a pre-validated OSCE
proportion of students approving the OSCE tests
Measured: at 3 months
Respiratory rate
Respiratory rate provided to the mannequin, number of chest excursions during each performance session.
Measured: approximately 15 minutes after having taken the course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startNov 2015
- Primary completion12 Dec 2018
- Study completion12 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Resuscitation of Newborn TrainingStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Pontifical Catholic University of Argentina, Fisher and Paykel Healthcare
- Responsible party
- Principal investigator, Edgardo Szyld, Icahn School of Medicine at Mount Sinai
- Investigators
- Egardo G. Szyld, MD, Principal investigator, Icahn School of Medicine at Mount SinaiDemian Szyld, MD, Principal investigator, New York Simulation Center for the Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847911
- Sponsor's protocol ID
- GCO 13-1336
- Status last verified
- Jan 2019
- First submitted
- 22 Apr 2013
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 33589725
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-directed Video Versus Instructor-based Neonatal Resuscitation Training of Novice Providers. A Controlled Blinded Randomized Non-inferiority Multicenter Study
- ClinicalTrials.gov ID
- NCT01847911
- Acronym / sponsor ID
- GCO 13-1336
- Conditions
- Resuscitation of Newborn Training
- Keywords
- self instructed resuscitation training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Pontifical Catholic University of Argentina, Fisher and Paykel Healthcare
- Study start
- Nov 2015
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 12 Dec 2018 (actual)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self instructed video learning | Experimental | Other: Self instructed video learningA 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 | Active comparator | Other: instructor trainingA standard hands-on training with a face-to-face instructor following a pre-validated OSCE program guidelines. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- previous experience in NRP
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self instructed video learningAlso: Self learning videoA 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 trainingAlso: face to face training in neonatal CPRa pre-validated OSCE neonatal resuscitation program | Other | instructor training |
Primary outcome
a pre-validated OSCE
Time frame: approximately 15 minutes after having taken the course
proportion of students completing the mandatory fields of the a pre-validated OSCE evaluation grid
3 secondary outcomes
a pre-validated OSCE
Time frame: approximately 15 minutes after having taken the course
a pre-validated OSCE
Time frame: at 3 months
Respiratory rate
Time frame: approximately 15 minutes after having taken the course
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Results publication: PubMed 33589725Szyld 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Egardo G. Szyld, MD principal investigator
Icahn School of Medicine at Mount Sinai
Demian Szyld, MD principal investigator
New York Simulation Center for the Health Sciences
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self instructed video learning and instructor training in people with Resuscitation of Newborn Training, run by Icahn School of Medicine at Mount Sinai at 7 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Argentina, Chile, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a pre-validated OSCE (time frame: approximately 15 minutes after having taken the course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01847911, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.