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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05613530
Acronym
MAXnéonat
Enrollment
50
Registered
2022-11-14
Start date
2021-05-19
Completion date
2022-05-01
Last updated
2022-11-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Simulation

Brief 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

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.

Interventions

BEHAVIORALMAX 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.

BEHAVIORALstandard of care

no cognitive aid but poster/paper only

Sponsors

Hospices Civils de Lyon
CollaboratorOTHER
Erasme University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
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).DAY 1the 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.

Secondary

MeasureTime frameDescription
non-technical skillsDay 1non-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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026