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

NCT03913533 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • Asphyxia Neonatorum
  • Birth Asphyxia

Interventions

DEVICE

Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method

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 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.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Georg Schmolzer, MD, PhD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
5 Minutes
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2021-04-30
Completion
2021-10-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03913533 on ClinicalTrials.gov