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Trial record 2 of 3 for:    18492509 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT03913533
Recruitment Status : Not yet recruiting
First Posted : April 12, 2019
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
University of Alberta

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.

Condition or disease Intervention/treatment Phase
Asphyxia Neonatorum Birth Asphyxia Device: Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method Device: Heart rate assessment using Tap-based smartphone application Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: the outcome assessed will be masked to group allocation
Primary Purpose: Diagnostic
Official Title: Standard 6-sec Method Versus Tap-based Application Method to Assess Heart Rate at Birth - a Randomized Controlled Trial
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
Active Comparator: Control group
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 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.

Experimental: Intervention group
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
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 Measures :
  1. Time to obtain Heart rate [ Time Frame: within the first 60 seconds form birth ]
    Time to obtain Heart rate form birth


Secondary Outcome Measures :
  1. Accuracy of heart rate assessment using either technique [ Time Frame: within the first 60 seconds form birth ]
    Accuracy of heart rate assessment using tap-based application or 6-sec method



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Ages Eligible for Study:   up to 5 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913533


Contacts
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Contact: Georg Schmolzer, MD, PhD 7807354647 georg.schmoelzer@me.com
Contact: Sylvia van OS 17806135237 Sylvia.Vanos@albertahealthservices.ca

Locations
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Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Sponsors and Collaborators
University of Alberta
Investigators
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Principal Investigator: Georg Schmolzer, MD, PhD University of Alberta

Publications of Results:

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03913533     History of Changes
Other Study ID Numbers: Pro00089994
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: requests can be made to the PI
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: once study is completed and published
Access Criteria: email requests to the PI

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Alberta:
Newborn
Heart rate assessment
Delivery Room
Additional relevant MeSH terms:
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Asphyxia Neonatorum
Asphyxia
Death
Pathologic Processes
Wounds and Injuries
Infant, Newborn, Diseases