Neonatal ResuscitationNCT03730025
Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation
A study testing Auscultation plus NeoTapAS and Auscultation without NeoTapAS in people with Neonatal Resuscitation and Heart Rate Assessment, run by University Hospital Padova at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neonatal Resuscitation, Heart Rate Assessment
- What is being tested?
- Auscultation plus NeoTapAS and Auscultation without NeoTapAS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 2 Nov 2018to 20 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All pediatric residents from third to fifth year of residency of the University of Piemonte Orientale who were trained on neonatal resuscitation
Who cannot join
- Lack of EC approval
- Lack of consent to record the scenario and to use the data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation: a Randomized Controlled Crossover Study
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.
Read the detailed description
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.
- Conditions
- Neonatal Resuscitation, Heart Rate Assessment
- Being tested
- Auscultation plus NeoTapAS, Auscultation without NeoTapAS
- Keywords
- Heart rate, Assessment, Time, Resuscitation intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auscultation plus NeoTapASOther
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 NeoTapASOther
Auscultation without NeoTapAS
| Study group | Role | What they receive |
|---|---|---|
| Auscultation plus NeoTapAS | Experimental | 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. Receives: Other: Auscultation plus NeoTapAS |
| Auscultation without NeoTapAS | Active comparator | Pediatric resident responsible for HR assessment will mentally calculate the HR based on auscultation (by counting the number of beats in 6 seconds and multiplying by 10) and will verbally communicate the calculated HR. Receives: Other: Auscultation without NeoTapAS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timing of the first HR communication.
Time elapsed from birth to the first HR communication
Measured: 1 min
Secondary outcomes (5)
Timing of the second HR communication
Measured: 2 min
Timing of the third HR communication
Measured: 3 min
Timing of the fourth HR communication
Measured: 4 min
Timing of resuscitation interventions (positive pressure ventilation, chest compressions, intubation and administration of first dose of adrenaline
Measured: 10 min
Timing of the fifth HR communication
Measured: 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study start2 Nov 2018
- Primary completion20 Nov 2018
- Study completion20 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Neonatal ResuscitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Padova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniele Trevisanuto, University Hospital Padova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730025
- Sponsor's protocol ID
- Novara2
- Status last verified
- Dec 2018
- First submitted
- 1 Nov 2018
- Last updated
- 24 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Binotti M, Cavallin F, Ingrassia PL, Pejovic NJ, Monzani A, Genoni G, Trevisanuto D. Heart rate assessment using NeoTapAdvancedSupport: a simulation study. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F440-F442. doi: 10.1136/archdischild-2018-315408. Epub 2018 Sep 27.
PubMed 30262463Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.
PubMed 26477415Myrnerts Hook S, Pejovic NJ, Marrone G, Tylleskar T, Alfven T. Accurate and fast neonatal heart rate assessment with a smartphone-based application - a manikin study. Acta Paediatr. 2018 Sep;107(9):1548-1554. doi: 10.1111/apa.14350. Epub 2018 Apr 22.
PubMed 29604115Murphy MC, De Angelis L, McCarthy LK, O'Donnell CPF. Comparison of infant heart rate assessment by auscultation, ECG and oximetry in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F490-F492. doi: 10.1136/archdischild-2017-314367. Epub 2018 May 25.
PubMed 29802102Chitkara R, Rajani AK, Oehlert JW, Lee HC, Epi MS, Halamek LP. The accuracy of human senses in the detection of neonatal heart rate during standardized simulated resuscitation: implications for delivery of care, training and technology design. Resuscitation. 2013 Mar;84(3):369-72. doi: 10.1016/j.resuscitation.2012.07.035. Epub 2012 Aug 25.
PubMed 22925993Cavallin F, Binotti M, Ingrassia PL, Genoni G, Rizzollo S, Monzani A, Trevisanuto D. Impact of a mobile application for heart rate assessment in simulated neonatal resuscitation: a randomised controlled cross-over study. Arch Dis Child Fetal Neonatal Ed. 2020 Jan;105(1):41-44. doi: 10.1136/archdischild-2018-316757. Epub 2019 May 17.
PubMed 31101662
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Mobile Application for Heart Rate Assessment in Simulated Neonatal Resuscitation: a Randomized Controlled Crossover Study
- ClinicalTrials.gov ID
- NCT03730025
- Acronym / sponsor ID
- Novara2
- Conditions
- Neonatal Resuscitation, Heart Rate Assessment
- Keywords
- Heart rate, Assessment, Time, Resuscitation intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital PadovaUniversity, hospital or other
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 20 Nov 2018 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 5 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Auscultation plus NeoTapAS | Experimental | Other: Auscultation plus NeoTapASPediatric 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 | Active comparator | Other: Auscultation without NeoTapASPediatric resident responsible for HR assessment will mentally calculate the HR based on auscultation (by counting the number of beats in 6 seconds and multiplying by 10) and will verbally communicate the calculated HR. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All pediatric residents from third to fifth year of residency of the University of Piemonte Orientale who were trained on neonatal resuscitation
Key exclusion criteria (2 listed)
- Lack of EC approval
- Lack of consent to record the scenario and to use the data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Auscultation plus NeoTapASPediatric 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. | Other | Auscultation plus NeoTapAS |
| Auscultation without NeoTapASAuscultation without NeoTapAS | Other | Auscultation without NeoTapAS |
Primary outcome
Timing of the first HR communication.
Time frame: 1 min
Time elapsed from birth to the first HR communication
5 secondary outcomes
Timing of the second HR communication
Time frame: 2 min
Timing of the third HR communication
Time frame: 3 min
Timing of the fourth HR communication
Time frame: 4 min
Timing of resuscitation interventions (positive pressure ventilation, chest compressions, intubation and administration of first dose of adrenaline
Time frame: 10 min
Timing of the fifth HR communication
Time frame: 5 min
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2018.
- Background: PubMed 30262463Binotti M, Cavallin F, Ingrassia PL, Pejovic NJ, Monzani A, Genoni G, Trevisanuto D. Heart rate assessment using NeoTapAdvancedSupport: a simulation study. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F440-F442. doi: 10.1136/archdischild-2018-315408. Epub 2018 Sep 27.
- Background: PubMed 26477415Wyllie J, Bruinenberg J, Roehr CC, Rudiger M, Trevisanuto D, Urlesberger B. European Resuscitation Council Guidelines for Resuscitation 2015: Section 7. Resuscitation and support of transition of babies at birth. Resuscitation. 2015 Oct;95:249-63. doi: 10.1016/j.resuscitation.2015.07.029. Epub 2015 Oct 15. No abstract available.
- Background: PubMed 29604115Myrnerts Hook S, Pejovic NJ, Marrone G, Tylleskar T, Alfven T. Accurate and fast neonatal heart rate assessment with a smartphone-based application - a manikin study. Acta Paediatr. 2018 Sep;107(9):1548-1554. doi: 10.1111/apa.14350. Epub 2018 Apr 22.
- Background: PubMed 29802102Murphy MC, De Angelis L, McCarthy LK, O'Donnell CPF. Comparison of infant heart rate assessment by auscultation, ECG and oximetry in the delivery room. Arch Dis Child Fetal Neonatal Ed. 2018 Sep;103(5):F490-F492. doi: 10.1136/archdischild-2017-314367. Epub 2018 May 25.
- Background: PubMed 22925993Chitkara R, Rajani AK, Oehlert JW, Lee HC, Epi MS, Halamek LP. The accuracy of human senses in the detection of neonatal heart rate during standardized simulated resuscitation: implications for delivery of care, training and technology design. Resuscitation. 2013 Mar;84(3):369-72. doi: 10.1016/j.resuscitation.2012.07.035. Epub 2012 Aug 25.
- Derived from this study: PubMed 31101662Cavallin F, Binotti M, Ingrassia PL, Genoni G, Rizzollo S, Monzani A, Trevisanuto D. Impact of a mobile application for heart rate assessment in simulated neonatal resuscitation: a randomised controlled cross-over study. Arch Dis Child Fetal Neonatal Ed. 2020 Jan;105(1):41-44. doi: 10.1136/archdischild-2018-316757. Epub 2019 May 17.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auscultation plus NeoTapAS and Auscultation without NeoTapAS in people with Neonatal Resuscitation and Heart Rate Assessment, run by University Hospital Padova at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timing of the first HR communication. (time frame: 1 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03730025, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2018.