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Time to Accurate Heart Rate on Neonatal Outcomes (GE-EKG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04587934
Recruitment Status : Completed
First Posted : October 14, 2020
Last Update Posted : December 13, 2021
Sponsor:
Collaborators:
GE Healthcare
Sharp Mary Birch Hospital for Women & Newborns
Information provided by (Responsible Party):
Sharp HealthCare

Study Description
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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
Premature Infant Extremely Low Birth Weight Extreme Prematurity Device: iRes Warmer with ResusView Other: iRes Warmer without ResusView Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : February 1, 2021
Actual Primary Completion Date : June 30, 2021
Actual Study Completion Date : December 10, 2021
Arms and Interventions
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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 Name: 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 Name: Standard of Care


Outcome Measures
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Primary Outcome Measures :
  1. Time to heart rate display in iRes Warmer with Resusview [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: Birth to 10 minutes of life ]
    Measure time from birth to application of Electrocardiogram electrodes from time of birth

  2. Is the rhythm recognized? [ Time Frame: Birth to 10 minutes of life ]
    Identify if a cardiac rhythm is recognized by Electrocardiogram monitor (Yes/No)

  3. Time to rhythm recognition [ Time Frame: Birth to 10 minutes of life ]
    Measure at what time the Warmer displays the baby's cardiac rhythm


Eligibility Criteria
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Information from the National Library of Medicine

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

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
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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): NCT04587934


Locations
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United States, California
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
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Principal Investigator: Anup Katheria, MD Sharp HealthCare
More Information
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Publications:
Neonatal Resuscitation. Vol. 7th edition. 2016, Elk Grove Village, IL: American Academy of Pediatrics.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sharp HealthCare
ClinicalTrials.gov Identifier: NCT04587934    
Other Study ID Numbers: GE-EKG
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: December 13, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data, particularly data that underlie the results reported in this article after deidentification will be available with other researchers, including data dictionaries for meta-analysis.
Supporting Materials: Study Protocol
Time Frame: Beginning 6 months and ending 36 months following article publication
Access Criteria: Data and publication are available at http://clinicaltrials.gov
URL: http://clinicaltrials.gov

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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:
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Birth Weight
Body Weight