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Mobile Application as a Clinical Decision Support Tool for Neonatal Resuscitation in the Delivery Room (MAXnéonat)

F

Free University of Brussels (ULB)

Status

Completed

Conditions

Simulation

Treatments

Behavioral: MAX NEONAT
Behavioral: standard of care

Study type

Interventional

Funder types

Other

Identifiers

NCT05613530
MAX néonat

Details and patient eligibility

About

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

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • All pediatric residents in Lyon and Caen University with at least a three-month clinical experience in a neonatal intensive care unit and one or more high fidelity neonatal resuscitation simulation sessions participation
  • All midwife students in Lyon and Caen which had benefited from teaching classes on neonatal resuscitation

Exclusion criteria

  • Participants who didn't attend one of the scheduled study sessions.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

50 participants in 2 patient groups

digital MAX néonat (intervention group or " MAX + group")
Experimental group
Description:
Participants use a digital, hand-held, cognitive aid (a mobile application named "MAX NEONAT") and the ILCOR 2020 algorithm poster. This group consists of a resident in pediatrics + 2 midwifes.
Treatment:
Behavioral: MAX NEONAT
MAX néonat on poster/paper (control group or " MAX - group")
Active Comparator group
Description:
Participants have no cognitive aid
Treatment:
Behavioral: standard of care

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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