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

Mobile Application (Max NEONAT) as a Clinical Support Tool for Neonatal Resuscitation in the Delivery Room: A Simulation-based Bicentric Randomized Controlled Trial.

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

Study Overview

• Status: Completed
• Conditions: Simulation
• Intervention / Treatment: Behavioral: MAX NEONAT; Behavioral: standard of care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • CHU Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: digital MAX néonat (intervention group or " MAX + group"); 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.	Behavioral: MAX NEONAT; 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.
Active Comparator: MAX néonat on poster/paper (control group or " MAX - group"); Participants have no cognitive aid	Behavioral: standard of care; no cognitive aid but poster/paper only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary outcome is a technical performance score, adapted from of a previously published checklist score. The technical score follows the (International Liaison Committee on Resuscitation recommendations (ILCOR).	the NRP checklist ( Neonatal Rescucitation Program) score we utilized is a previously published technical performance score adapted from the ILCOR 2020 recommendations. This revised NRP score is composed of 27 points. For each action, trinomials are given a score of 0 for not performing the action, 1 for performing the task correctly and in order.	DAY 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
non-technical skills	non-technical skills, evaluated by an adaptation of a previously published checklist score. The non-technical score includes three categories: leadership, teamwork and task management. The score has a total of 36 points. A questionnaire evaluating the functionality and usefulness of the mobile phone application will be analyzed.	Day 1

Collaborators and Investigators

• Sponsor: Erasme University Hospital
• Collaborators: CHU LYON
• Investigators: Principal Investigator: Anne Beissel, MD, CHU Lyon

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2021
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: November 6, 2022
• First Submitted That Met QC Criteria: November 6, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 23, 2022
• Last Update Submitted That Met QC Criteria: November 20, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: MAX néonat

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No