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Heart Rate Assessment at Birth Comparing Stethoscope Versus Tap-based Application

Primary Purpose

Asphyxia Neonatorum, Birth Asphyxia

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method
Heart rate assessment using Tap-based smartphone application
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Asphyxia Neonatorum focused on measuring Newborn, Heart rate assessment, Delivery Room

Eligibility Criteria

undefined - 5 Minutes (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All newborn infants delivered in the Royal Alexandra Hospital (RAH) 22+0-41+6 weeks gestation.

Exclusion Criteria:

  • Infants will be excluded if parents refused to consent to the study.

Sites / Locations

  • Royal Alexandra Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Intervention group

Arm Description

Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate by listening to the heart beat for 6-sec and then compute the heart rate of the newborn infant.

Heart rate assessment using Tap-based smartphone application At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate using a Tap-based smartphone application by tapping the screen for 3 beats at that time a heart rate will be displayed.

Outcomes

Primary Outcome Measures

Time to obtain Heart rate
Time to obtain Heart rate form birth

Secondary Outcome Measures

Accuracy of heart rate assessment using either technique
Accuracy of heart rate assessment using tap-based application or 6-sec method

Full Information

First Posted
March 22, 2019
Last Updated
September 3, 2021
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT03913533
Brief Title
Heart Rate Assessment at Birth Comparing Stethoscope Versus Tap-based Application
Official Title
Standard 6-sec Method Versus Tap-based Application Method to Assess Heart Rate at Birth - a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Withdrawn
Why Stopped
No funding obtained
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
October 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Some newborn babies have difficulty breathing at birth and need help. When babies need help with breathing the clinical team, the team measures heart rate using a stethoscope to check its heart rate and figure out what kind of help they will need. If the heart rate is too low, the clinical team will begin to inflate the baby's lung. Knowing the baby's heart rate quickly is important but the stethoscope is inaccurate, and might delay start of resuscitation. Using a smartphone app that uses screen tapping with a stethoscope could allow heart rate to be measured much faster compared to the stethoscope and allow the clinical team to support the baby's needs better immediately after birth.
Detailed Description
Purpose Nearly 10% of all infants born worldwide require respiratory support at birth and birth asphyxia remains one of the leading causes of infant morbidity and mortality. Neonatal resuscitation is the most effective strategy to deal with this condition. Moreover, an infant's heart rate (HR) is the most significant clinical parameter used to assess the need for and response to neonatal resuscitation. Currently, a newborn's HR is determined by auscultating or palpating of the umbilical cord. Although auscultation is more precise compared to palpation, both methods are inaccurate and tend to underestimate HR. The current resuscitation guidelines also recommend using electrocardiogram (ECG) and pulse oximetry, which allow for continuous monitoring, however are slow to apply and detect HR compared to stethoscopes. During neonatal resuscitation, an infant's HR is necessary to initiate resuscitation and to monitor the effectiveness of each intervention and therefore it becomes essential to accurately and quickly assess an infant's HR during this process. If HR is detected slowly or inaccurately, there is an increased risk that necessary interventions are not started or that certain interventions are prolonged, which could lead to increased morbidity and mortality of the infants. The recent advances in technology, namely the development of a smartphone tap application for HR assessment is promising as a novel tool for quick and accurate HR detection during neonatal resuscitation. Hypothesis The use of a tap-based smartphone application will be faster and more accurate when compared to standard auscultation with the 6-sec method to assess HR. Justification Simulation studies have shown that it is feasible to measure HR using a tap-based application. Moreover, the investigator's group has recently shown its reliability in an animal model of asphyxia-induced neonatal swine. The investigator showed its accuracy compared to the experimental gold standard carotid blood flow-derived HR assessments and report a median time of 3 sec for assessment, which is less than the current recommended time for auscultation. However, no study has been performed in the delivery room in newborn babies at birth. Therefore, the investigator aim to compare the tap-based application to the current 6-sec standard approach to assess HR during neonatal resuscitation in the delivery room. Ehe investigator anticipate this study will allow us to determine the most reliable approach for initial assessment to reduce neonatal morbidity and mortality outcomes. Objectives To examine (i) accuracy and (ii) speed to assess HR using auscultation with a tap-based application during neonatal resuscitation. Research Method/Procedures The proposed study is a randomized controlled trial comparing two different approaches to accurately assess HR. The investigator will compare the routinely used Neonatal Resuscitation Program 6-sec method with a stethoscope using two different methods of auscultation [6-sec method and tap-based method (NeoTapLS, Tap4Life, Stockholm, Sweden)] to accurately assess HR immediately after birth. The investigator aim to collect the data over a period of 12 months. Two investigators in addition to the clinical team will attend the delivery of newborn infants. Immediately after birth the infant will be placed on a resuscitation trolley where a pulse oximeter will be attached to the right hand. At the same time three ECG leads will be placed on the infant's chest. Simultaneously the stethoscope will be placed by one of the investigators on the infants' chest to obtain the HR . In the alternative setup, stethoscope will be used in combination with the tap-based application. In both setups, the time needed to display a HR will be recorded for all devices. All infants will have routine HR measured using ECG, which will be used as comparison for accuracy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asphyxia Neonatorum, Birth Asphyxia
Keywords
Newborn, Heart rate assessment, Delivery Room

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
the outcome assessed will be masked to group allocation
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate by listening to the heart beat for 6-sec and then compute the heart rate of the newborn infant.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Heart rate assessment using Tap-based smartphone application At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate using a Tap-based smartphone application by tapping the screen for 3 beats at that time a heart rate will be displayed.
Intervention Type
Device
Intervention Name(s)
Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method
Intervention Description
Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate by listening to the heart beat for 6-sec and then compute the heart rate of the newborn infant.
Intervention Type
Device
Intervention Name(s)
Heart rate assessment using Tap-based smartphone application
Intervention Description
At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate using a Tap-based smartphone application by tapping the screen for 3 beats at that time a heart rate will be displayed.
Primary Outcome Measure Information:
Title
Time to obtain Heart rate
Description
Time to obtain Heart rate form birth
Time Frame
within the first 60 seconds form birth
Secondary Outcome Measure Information:
Title
Accuracy of heart rate assessment using either technique
Description
Accuracy of heart rate assessment using tap-based application or 6-sec method
Time Frame
within the first 60 seconds form birth

10. Eligibility

Sex
All
Maximum Age & Unit of Time
5 Minutes
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All newborn infants delivered in the Royal Alexandra Hospital (RAH) 22+0-41+6 weeks gestation. Exclusion Criteria: Infants will be excluded if parents refused to consent to the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Schmolzer, MD, PhD
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
requests can be made to the PI
IPD Sharing Time Frame
once study is completed and published
IPD Sharing Access Criteria
email requests to the PI
Citations:
PubMed Identifier
16188811
Citation
Saugstad OD, Ramji S, Rootwelt T, Vento M. Response to resuscitation of the newborn: early prognostic variables. Acta Paediatr. 2005 Jul;94(7):890-5. doi: 10.1111/j.1651-2227.2005.tb02007.x.
Results Reference
result
PubMed Identifier
26473001
Citation
Wyckoff MH, Aziz K, Escobedo MB, Kapadia VS, Kattwinkel J, Perlman JM, Simon WM, Weiner GM, Zaichkin JG. Part 13: Neonatal Resuscitation: 2015 American Heart Association Guidelines Update for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2015 Nov 3;132(18 Suppl 2):S543-60. doi: 10.1161/CIR.0000000000000267. No abstract available.
Results Reference
result
PubMed Identifier
26874298
Citation
Duryea EL, Nelson DB, Wyckoff MH, Grant EN, Tao W, Sadana N, Chalak LF, McIntire DD, Leveno KJ. The impact of ambient operating room temperature on neonatal and maternal hypothermia and associated morbidities: a randomized controlled trial. Am J Obstet Gynecol. 2016 Apr;214(4):505.e1-505.e7. doi: 10.1016/j.ajog.2016.01.190. Epub 2016 Feb 10.
Results Reference
result
PubMed Identifier
16989935
Citation
Kamlin CO, O'Donnell CP, Everest NJ, Davis PG, Morley CJ. Accuracy of clinical assessment of infant heart rate in the delivery room. Resuscitation. 2006 Dec;71(3):319-21. doi: 10.1016/j.resuscitation.2006.04.015. Epub 2006 Sep 20.
Results Reference
result
PubMed Identifier
18492509
Citation
Kamlin CO, Dawson JA, O'Donnell CP, Morley CJ, Donath SM, Sekhon J, Davis PG. Accuracy of pulse oximetry measurement of heart rate of newborn infants in the delivery room. J Pediatr. 2008 Jun;152(6):756-60. doi: 10.1016/j.jpeds.2008.01.002. Epub 2008 Mar 6.
Results Reference
result
PubMed Identifier
11900034
Citation
Kopotic RJ, Lindner W. Assessing high-risk infants in the delivery room with pulse oximetry. Anesth Analg. 2002 Jan;94(1 Suppl):S31-6.
Results Reference
result
PubMed Identifier
30538976
Citation
Luong DH, Cheung PY, O'Reilly M, Lee TF, Schmolzer GM. Electrocardiography vs. Auscultation to Assess Heart Rate During Cardiac Arrest With Pulseless Electrical Activity in Newborn Infants. Front Pediatr. 2018 Nov 27;6:366. doi: 10.3389/fped.2018.00366. eCollection 2018.
Results Reference
result
PubMed Identifier
29895572
Citation
Patel S, Cheung PY, Solevag AL, Barrington KJ, Kamlin COF, Davis PG, Schmolzer GM. Pulseless electrical activity: a misdiagnosed entity during asphyxia in newborn infants? Arch Dis Child Fetal Neonatal Ed. 2019 Mar;104(2):F215-F217. doi: 10.1136/archdischild-2018-314907. Epub 2018 Jun 12.
Results Reference
result
PubMed Identifier
15036740
Citation
Owen CJ, Wyllie JP. Determination of heart rate in the baby at birth. Resuscitation. 2004 Feb;60(2):213-7. doi: 10.1016/j.resuscitation.2003.10.002.
Results Reference
result
PubMed Identifier
20483522
Citation
Voogdt KG, Morrison AC, Wood FE, van Elburg RM, Wyllie JP. A randomised, simulated study assessing auscultation of heart rate at birth. Resuscitation. 2010 Aug;81(8):1000-3. doi: 10.1016/j.resuscitation.2010.03.021. Epub 2010 May 18.
Results Reference
result
PubMed Identifier
30262463
Citation
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.
Results Reference
result

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Heart Rate Assessment at Birth Comparing Stethoscope Versus Tap-based Application

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