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NCT Number: NCT03730025

Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation

NeoTapAdvancedSupport (NeoTapAS) is a free-of-charge mobile application that showed good accuracy in HR estimation. This study aims to evaluate the impact of NeoTapAS on timing of HR communication and of resuscitation interventions in a high fidelity simulation scenario.

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Key information

Conditions

Neonatal Resuscitation Heart Rate Assessment

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Piemonte Orientale

Novara, Italy

About this study

Assessing the HR by auscultation can be limited due to imprecise auscultation and/or errors in mental computation, leading to inappropriate or delayed resuscitation. Previous studies evaluated a free-of-charge mobile application (NeoTapAdvancedSupport, NeoTapAS) to help HR assessment in a simulated scenario of neonatal resuscitation. NeoTapAS showed good accuracy in estimating HR and could be a useful tool in resource-constrained settings.

Another potential advantage of using NeoTapAS may be the anticipation of HR communication during resuscitation, because it avoids mental computation and possible errors due to the stressful situation. In addition, prompt HR assessment may lead to anticipating resuscitation interventions. However, these hypotheses remain to be demonstrated.

The aim of this study is to evaluate the promptness in HR communication using NeoTapAS compared with mental computation in a high-fidelity simulated newborn resuscitation scenario. In addition, the impact of NeoTapAS on timing of resuscitation procedures will be investigated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All pediatric residents from third to fifth year of residency of the University of Piemonte Orientale who were trained on neonatal resuscitation

Exclusion criteria

  • Lack of EC approval
  • Lack of consent to record the scenario and to use the data

Treatment and study plan

Auscultation plus NeoTapAS

Other

Pediatric resident responsible for HR assessment will estimate the HR by listening to the praecordium with a stethoscope. When using NeoTapAS, he/she will simultaneously tap the same pace on the screen of an iPad with the NeoTapAS app installed and will verbally communicate the HR displayed on the screen.

Auscultation without NeoTapAS

Other

Auscultation without NeoTapAS

Primary outcomes

  1. Timing of the first HR communication.

    Time frame: 1 min

    Time elapsed from birth to the first HR communication

Secondary outcomes

  1. Timing of the second HR communication

    Time frame: 2 min

  2. Timing of the third HR communication

    Time frame: 3 min

  3. Timing of the fourth HR communication

    Time frame: 4 min

  4. Timing of resuscitation interventions (positive pressure ventilation, chest compressions, intubation and administration of first dose of adrenaline

    Time frame: 10 min

  5. Timing of the fifth HR communication

    Time frame: 5 min

Sponsors and collaborators

Lead sponsor

University Hospital Padova

Other

Registry information

Official study title

Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation: a Randomized Controlled Crossover Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Nov 5, 2018
Registry last updated
Dec 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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