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GE-EKG: Time to Accurate Heart Rate on Neonatal Outcomes

Sponsor
Sharp HealthCare (Other)
Overall Status
Completed
CT.gov ID
NCT04587934
Collaborator
GE Healthcare (Industry), Sharp Mary Birch Hospital for Women & Newborns (Other)
42
Enrollment
1
Location
2
Arms
10.3
Actual Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g. Cardiopulmonary resuscitation or breathing assistance) of premature newborns (23 to 32+6 weeks gestation).

Condition or Disease Intervention/Treatment Phase
  • Device: iRes Warmer with ResusView
  • Other: iRes Warmer without ResusView
 N/A

Detailed Description

This is a prospective interventional randomized control trial. Infants born between 23+0 and 32+6 estimated gestational age will be randomized using a computer generate allocation sequence stratified by gestational age. Randomization cards will be placed in opaque envelopes. For the intervention group, the care team will use the Panda iRes Warmer with ResusView Bed during resuscitation interventions in the first 10 minutes of life. During use of the iRes-warmer, standard nursing care of an infant on a radiant warmer will be followed. Participants assigned to the control group will receive interventions using the same model Panda bed without ResusView. There is no minimum time for monitoring, and the maximum time depends on clinical determination for use of heart rate feature for each resuscitation event. Data including the infant's gestational age, Electrocardiogram lead type and activities that occurred during resuscitation will be recorded for the first 10 minutes of life.

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Time to Accurate Heart Rate on Neonatal Outcomes
Actual Study Start Date :
Feb 1, 2021
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Dec 10, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: iRes Warmer with ResusView

iRes Warmer with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.

Device: iRes Warmer with ResusView
Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age
Other Names:
  • Panda Bed with ECG Feature

    		•
    Active Comparator: iRes Warmer without ResusView

    An external non-experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation.

    Other: iRes Warmer without ResusView
    Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age
    Other Names:
  • Standard of Care

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to heart rate display in iRes Warmer with Resusview [Birth to 10 minutes of life]

      Measure time from birth to heart rate displayed on monitor following lead placement

    Secondary Outcome Measures

    1. Time to first change in Fraction of inspired oxygen [Birth to 10 minutes of life]

      Measure time from birth to first increase or decrease in fraction of inspired oxygen from ECG lead placement

    2. Time to first change in airway pressure [Birth to 10 minutes of life]

      Measure time from birth to first increase or decrease in airway pressure from ECG lead placement

    3. Time to initiation of Positive Pressure Ventilation (PPV) [Birth to 10 minutes of life]

      Measure time from birth to start of PPV following first heart rate display

    Other Outcome Measures

    1. Time of electrode placement [Birth to 10 minutes of life]

      Measure time from birth to application of Electrocardiogram electrodes from time of birth

    2. Is the rhythm recognized? [Birth to 10 minutes of life]

      Identify if a cardiac rhythm is recognized by Electrocardiogram monitor (Yes/No)

    3. Time to rhythm recognition [Birth to 10 minutes of life]

      Measure at what time the Warmer displays the baby's cardiac rhythm

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    23 Weeks to 32 Weeks
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Infants who are delivered to mothers over the age of 16 years of age

    • Infants delivered at 23+0 to 32+6 weeks estimated gestational age based on the best obstetric estimate at the time of delivery.

    • Infants without known congenital malformations prior to delivery

    • Antenatal consent

    Exclusion Criteria:

    • Infants who are delivered to mothers under the age of 16 years of age

    • Known congenital anomalies of newborn prior to delivery

    • Cardiac defects other than small Ventricular septum defect and Patent ductus arteriosus

    • Multiples

    • Declined consent

    • iRes Warmer with ResusView not available at time of delivery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sharp Mary Birch Hospital for Women and Newborns San Diego California United States 92123

    Sponsors and Collaborators

    • Sharp HealthCare
    • GE Healthcare
    • Sharp Mary Birch Hospital for Women & Newborns

    Investigators

    • Principal Investigator: Anup Katheria, MD, Sharp HealthCare

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sharp HealthCare
    ClinicalTrials.gov Identifier:
    NCT04587934
    Other Study ID Numbers:
    • GE-EKG
    First Posted:
    Oct 14, 2020
    Last Update Posted:
    Dec 13, 2021
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Sharp HealthCare
    electrocardiogram
    Neonatal Resuscitation
    resuscitation of premature infants
    Additional relevant MeSH terms:
    Birth Weight

    Study Results

    No Results Posted as of Dec 13, 2021