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Completed

NCT Number: NCT02932683

MedNav: Improving Neonatal Life Support (NLS)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chelsea and Westminster NHS Foundation trust

London, sw10 9nh, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Imperial Medical students Novice to Neonatal resuscitation Medical students with1 year of clinical experience.

Exclusion criteria

Previous Neonatal training,

Treatment and study plan

MedNav

Device

MedNav is a tablet based platform that uses auditory and visual cues to prompt people to perform the correct steps in neonatal resuscitation.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Confidence in performing neonatal resuscitation

    Time frame: 0 weeks and 7 weeks post teaching

    Confidence as marked on a 7 point Likert scale

Sponsors and collaborators

Lead sponsor

Chelsea and Westminster NHS Foundation Trust

Other

Registry information

Official study title

Mednav: A Randomised Control Trial of Novice Users of Mednav a Neonatal Resuscitation Device at 0 and 7 Weeks Follow up.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 13, 2016
Registry last updated
Oct 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.