Clinical trial NCT02932683: MedNav: Improving Neonatal Life Support (NLS)
Official title: Mednav: A Randomised Control Trial of Novice Users of Mednav a Neonatal Resuscitation Device at 0 and 7 Weeks Follow up.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Showing No Response to Resuscitation
Keywords: Resuscitation
Neonatal
Education
Lead sponsor: Chelsea and Westminster NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-10-13
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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

1. No MedNav on performing NLS (control arm)
2. 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

Previous Neonatal training,

Primary outcomes:
measure: Ability to perform Neonatal Resuscitation on a mannequin immediately and at 7 weeks following teaching.
timeFrame: 7 weeks
Secondary outcomes:
measure: Confidence in performing neonatal resuscitation
timeFrame: 0 weeks and 7 weeks post teaching
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Chelsea and Westminster NHS Foundation trust
Study officials:
affiliation: Chelsea and Westminster Hospital
name: Shane P Duffy, MBChB
role: STUDY_DIRECTOR
References: