Mobile Application as a Clinical Decision Support Tool for Neonatal Resuscitation in the Delivery Room
Condition: Simulation
Study type: Interventional

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.
    

Intervention name(s): MAX NEONAT; standard of care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; no cognitive aid but poster/paper only
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention