Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05613530 |
| Other study ID # |
MAX néonat |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 19, 2021 |
| Est. completion date |
May 1, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
Erasme University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The need for neonatal cardiopulmonary resuscitation in the delivery room is rare with less
than 1% of newborns requiring advanced resuscitation. The use of clinical decision support
tools to guide practitioners on medical procedure steps is recognized by the medical
community. In this randomized bi-centric controlled study, we investigate the effect of a
mobile phone application on technical and non-technical performance of student trinomials
managing simulated critical neonatal events
Description:
The need for neonatal cardiopulmonary resuscitation in the delivery room is rare with less
than 1% of newborns requiring advanced resuscitation: Approximately 85% of babies born at
term will initiate breathing spontaneously at birth. An additional 10% will do so in response
to stimulation and drying. However, approximately 5% of term infants receive
positive-pressure ventilation to successfully transition, 2% are intubated, 0.1% receive
cardiac compressions, and 0.05% receive compressions with Epinephrine. These events are rare
but stressful and require fast response. High stress impairs cognitive skills, including
decision making, short-term memory, knowledge recall, and situational attention. In order to
help practitioners, guidelines and algorithm exists: The neonatal resuscitation program (NRP)
and International Liaison Committee on Resuscitation (ILCOR) algorithm outlines essential
steps to take to assist a neonate immediately after birth. ILCOR algorithm poster is present
in every delivery room in France. Nevertheless, studies have shown a 16-55% error rate in
adherence to the NRP algorithm. Despite periodic training skills deterioration, technical
performance, and aptitude to follow recommendations decline over time.
The use of cognitive aids might be a solution to prevent errors in critical situation.
Cognitive aids are defined as "prompts designed to help users complete a task or series of
tasks." The design of cognitive aids includes posters, checklists, mnemonics, or digital
tools like computer programs or smartphone applications. Poster or checklist cognitive aids
are widely used to help health care to follow standardized procedures while facing
high-cognitive loads situations. Many digital cognitive aids have been developed in intensive
care (cardiac arrest) and anesthesiology both in adult and pediatric fields. They have been
shown to improve technical skills along with guideline adherence in adult's study. Influence
of cognitive aids on technical and nontechnical skills has not been investigated extensively
and is still controversial in pediatrics. In neonatology some studies exist but with
discordant results. MAX (Medical Assistance eXpert) is a mobile French cognitive aid
available on smartphone or tablet. The use of MAX has been shown to improve technical and
nontechnical skill in previous adult studies. To evaluate the usefulness of digital cognitive
aid in neonatal critical situations, ILCOR 2020 algorithm was included in MAX. A previous
unpublished pilot study in neonatal simulated cardiopulmonary arrest shown feasibility in
trinomials and improvement in technical skill.
We performed an unblinded randomized trial comparing the use of a digital, hand-held,
cognitive aid (a mobile application named "MAX NEONAT") and the ILCOR 2020 algorithm poster,
vs. without cognitive aid, to test the hypothesis that MAX NEONAT could improve technical
performance and affect non-technical performance of pediatric residents and mid wife-students
facing simulated neonatal cardiac arrest.
