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Completed

NCT Number: NCT04587934

Time to Accurate Heart Rate on Neonatal Outcomes

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).

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Key information

Age range

23 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, 92123, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iRes Warmer with ResusView

Device

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

iRes Warmer without ResusView

Other

Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age

Other names: Standard of Care

Primary outcomes

  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 outcomes

  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 outcomes

  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. EKG Waveform Displayed by Rapid EKG Algorithm During Resuscitation

    Time frame: Birth to 10 minutes of life

    Identify if a cardiac rhythm is recognized by Electrocardiogram monitor algorithm and displays a waveform during resuscitation (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

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Collaborators

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

Registry information

Acronym: GE-EKG

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
Jan 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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