Infant Showing No Response to ResuscitationNCT02932683
MedNav: Improving Neonatal Life Support (NLS)
A study testing MedNav in people with Infant Showing No Response to Resuscitation, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study was designed to evaluate if MedNav impacts the ability of novice resuscitators to perform Neonatal Life Support (NLS) in the simulated environment, and if this ability is maintained after a 7 week period. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infant Showing No Response to Resuscitation
- What is being tested?
- MedNav
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Apr 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Imperial Medical students Novice to Neonatal resuscitation Medical students with1 year of clinical experience.
Who cannot join
- Previous Neonatal training,
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Chelsea and Westminster NHS Foundation trust
London, sw10 9nh
About this study
Official title: Mednav: A Randomised Control Trial of Novice Users of Mednav a Neonatal Resuscitation Device at 0 and 7 Weeks Follow up.
This study was designed to evaluate if MedNav impacts the ability of novice resuscitators to perform Neonatal Life Support (NLS) in the simulated environment, and if this ability is maintained after a 7 week period. Testing the nul hypothesis that there is no difference in technical skill completion when performing neonatal resuscitation on a mannequin with or without MedNav, immediately after training or after a period of 7 weeks since the training episode.
Read the detailed description
Novices resuscitators (Medical Students) were invited to attend a 2 hour teaching session on neonatal resuscitation.
To ensure that the differences in outcome of Neonatal Life Support (NLS) learning are attributable to MedNav only, a simple randomisation process was carried out just prior to testing, where candidates pulled out a folded piece of paper assigning them to either
- No MedNav on performing NLS (control arm)
- Assistance of MedNav when performing NLS
Blinding/masking was not possible for either the candidate or faculty as the testing process involved the use of a tablet device to display the MedNav system.
On entering the room, candidates stated whether they were using MedNav or not. Each candidate was given an identical neonatal resuscitation scenario and technical skills in neonatal resuscitation were assessed using a 12-point mark sheet adapted from the Neonatal Life Support course provided by the UK Resuscitation Council. After testing, all candidates were asked to assess their confidence in performing NLS using a seven point Likert scale.
Candidates were subsequently invited back for a follow-up session at 7 weeks. Testing of the same NLS scenario was undertaken with participants staying in their initial allocation groups. Again technical skills were assessed based on the UK resuscitation council mark sheet and candidates were asked to rate their confidence on NLS after.
For further analysis, a small sample of 9 students from the "non-MedNav" group were asked to perform NLS with the use of MedNav immediately after their secondary testing at 7 weeks. The investigators aim here was to assess if this crossover group had a significant improvement in their task completion owing largely to the use of MedNav.
- Being tested
- MedNav
- Keywords
- Resuscitation, Neonatal, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MedNavDevice
MedNav is a tablet based platform that uses auditory and visual cues to prompt people to perform the correct steps in neonatal resuscitation.
| Study group | Role | What they receive |
|---|---|---|
| MedNav assisted resuscitators | Experimental | MedNav will be used to perform neonatal resuscitation on a mannequin and assessed after teaching and 7 weeks after intervention, following this a small group will be used as a cross over study. Receives: Device: MedNav |
| No MedNav resuscitators | No intervention | Neonatal resuscitation will be performed on a mannequin (without the use of MedNav) and assessed after teaching and 7 weeks after intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability to perform Neonatal Resuscitation on a mannequin immediately and at 7 weeks following teaching.
Neonatal resuscitation will be assessed as defined by task completion based on an assessment sheet adapted from the resuscitation councils NLS course assessment.
Measured: 7 weeks
Secondary outcomes (1)
Confidence in performing neonatal resuscitation
Confidence as marked on a 7 point Likert scale
Measured: 0 weeks and 7 weeks post teaching
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study startOct 2015
- Primary completionFeb 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant Showing No Response to ResuscitationStudies of the same condition, open and under way.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea and Westminster NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shane P Duffy, MBChB, Study director, Chelsea and Westminster Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932683
- Sponsor's protocol ID
- ChelseaNHS
- Status last verified
- Oct 2016
- First submitted
- 12 Oct 2016
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mednav: A Randomised Control Trial of Novice Users of Mednav a Neonatal Resuscitation Device at 0 and 7 Weeks Follow up.
- ClinicalTrials.gov ID
- NCT02932683
- Acronym / sponsor ID
- ChelseaNHS
- Keywords
- Resuscitation, Neonatal, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Chelsea and Westminster NHS Foundation TrustUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 13 Oct 2016 (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.
This study was designed to evaluate if MedNav impacts the ability of novice resuscitators to perform Neonatal Life Support (NLS) in the simulated environment, and if this ability is maintained after a 7 week period. Testing the nul hypothesis that there is no difference in technical skill completion when performing neonatal resuscitation on a mannequin with or without MedNav, immediately after training or after a period of 7 weeks since the training episode.
Detailed description
Novices resuscitators (Medical Students) were invited to attend a 2 hour teaching session on neonatal resuscitation.
To ensure that the differences in outcome of Neonatal Life Support (NLS) learning are attributable to MedNav only, a simple randomisation process was carried out just prior to testing, where candidates pulled out a folded piece of paper assigning them to either
- No MedNav on performing NLS (control arm)
- Assistance of MedNav when performing NLS
Blinding/masking was not possible for either the candidate or faculty as the testing process involved the use of a tablet device to display the MedNav system.
On entering the room, candidates stated whether they were using MedNav or not. Each candidate was given an identical neonatal resuscitation scenario and technical skills in neonatal resuscitation were assessed using a 12-point mark sheet adapted from the Neonatal Life Support course provided by the UK Resuscitation Council. After testing, all candidates were asked to assess their confidence in performing NLS using a seven point Likert scale.
Candidates were subsequently invited back for a follow-up session at 7 weeks. Testing of the same NLS scenario was undertaken with participants staying in their initial allocation groups. Again technical skills were assessed based on the UK resuscitation council mark sheet and candidates were asked to rate their confidence on NLS after.
For further analysis, a small sample of 9 students from the "non-MedNav" group were asked to perform NLS with the use of MedNav immediately after their secondary testing at 7 weeks. The investigators aim here was to assess if this crossover group had a significant improvement in their task completion owing largely to the use of MedNav.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MedNav assisted resuscitators | Experimental | Device: MedNavMedNav will be used to perform neonatal resuscitation on a mannequin and assessed after teaching and 7 weeks after intervention, following this a small group will be used as a cross over study. |
| No MedNav resuscitators | No intervention | –Neonatal resuscitation will be performed on a mannequin (without the use of MedNav) and assessed after teaching and 7 weeks after intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Imperial Medical students Novice to Neonatal resuscitation Medical students with1 year of clinical experience.
Key exclusion criteria (1 listed)
- Previous Neonatal training,
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 |
|---|---|---|
| MedNavMedNav is a tablet based platform that uses auditory and visual cues to prompt people to perform the correct steps in neonatal resuscitation. | Device | MedNav assisted resuscitators |
Primary outcome
Ability to perform Neonatal Resuscitation on a mannequin immediately and at 7 weeks following teaching.
Time frame: 7 weeks
Neonatal resuscitation will be assessed as defined by task completion based on an assessment sheet adapted from the resuscitation councils NLS course assessment.
1 secondary outcome
Confidence in performing neonatal resuscitation
Time frame: 0 weeks and 7 weeks post teaching
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 14 Oct 2016.
- Individual participant dataSharing planned: No
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.
Shane P Duffy, MBChB study director
Chelsea and Westminster Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MedNav in people with Infant Showing No Response to Resuscitation, run by Chelsea and Westminster NHS Foundation Trust at 1 site in United Kingdom.
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 1 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 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Ability to perform Neonatal Resuscitation on a mannequin immediately and at 7 weeks following teaching. (time frame: 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2016.