Clinical trial NCT03913533: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Asphyxia Neonatorum
Birth Asphyxia
Keywords: Newborn
Heart rate assessment
Delivery Room
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 0
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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

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.

Primary outcomes:
measure: Time to obtain Heart rate
timeFrame: within the first 60 seconds form birth
Secondary outcomes:
measure: Accuracy of heart rate assessment using either technique
timeFrame: within the first 60 seconds form birth
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
Study officials:
affiliation: University of Alberta
name: Georg Schmolzer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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