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

NCT05613530 | Completed

• 1 other identifier: MAX néonat
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Simulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• non-technical skills

  Day 1

Study Arms (2)

digital MAX néonat (intervention group or " MAX + group")

EXPERIMENTAL

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

MAX néonat on poster/paper (control group or " MAX - group")

ACTIVE COMPARATOR

Participants have no cognitive aid

Behavioral: standard of care

Interventions

MAX NEONAT BEHAVIORAL

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.

digital MAX néonat (intervention group or " MAX + group")

standard of care BEHAVIORAL

no cognitive aid but poster/paper only

MAX néonat on poster/paper (control group or " MAX - group")

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Erasme University Hospital: lead
• Hospices Civils de Lyon: collaborator

Study Sites (1)

CHU LYON

Lyon, France

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anne Beissel, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Director

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: November 14, 2022
• Study Start: May 19, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: November 23, 2022

Record last verified: 2022-11

Locations

FR (1)