NCT02932683

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 12, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 13, 2016

Completed
Last Updated

October 14, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

October 12, 2016

Last Update Submit

October 13, 2016

Conditions

Infant Showing No Response to Resuscitation

Keywords

ResuscitationNeonatalEducation

Outcome Measures

Primary Outcomes (1)

  • 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.

    7 weeks

Secondary Outcomes (1)

  • Confidence in performing neonatal resuscitation

    0 weeks and 7 weeks post teaching

Study Arms (2)

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.

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.

Interventions

MedNavDEVICE

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

MedNav assisted resuscitators

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Previous Neonatal training,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chelsea and Westminster NHS Foundation trust

London, sw10 9nh, United Kingdom

Location

Study Officials

  • Shane P Duffy, MBChB

    Chelsea and Westminster Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 12, 2016

First Posted

October 13, 2016

Study Start

October 1, 2015

Primary Completion

February 1, 2016

Study Completion

April 1, 2016

Last Updated

October 14, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)