An interventional study of Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method and Heart rate assessment using Tap-based smartphone application in Asphyxia Neonatorum and Birth Asphyxia, sponsored by University of Alberta. Withdrawn at 1 site in Canada. Open to participants aged Up to 5 Minutes. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by University of Alberta · Not applicable, Interventional, and Diagnostic
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.
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
113 studies on the registry are indexed under Asphyxia Neonatorum; 24 are open to participants now.
Browse Asphyxia Neonatorum studies →University of Alberta is the lead sponsor of 819 studies on the registry; 166 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
Device: Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method
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.
Device: Heart rate assessment using Tap-based smartphone application
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.
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.
Time to obtain Heart rate
Time to obtain Heart rate form birth
Time frame: within the first 60 seconds form birth
Accuracy of heart rate assessment using either technique
Accuracy of heart rate assessment using tap-based application or 6-sec method
Time frame: within the first 60 seconds form birth
Plan to share: Yes — requests can be made to the PI
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: once study is completed and published
Access criteria: email requests to the PI
This study is withdrawn, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.