Time to Accurate Heart Rate on Neonatal Outcomes

Overview

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 30, 2021

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.

Interventions

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

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 23 Weeks

Maximum Age: 32 Weeks

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Sharp HealthCare
  • Collaborator
    • GE Healthcare
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Anup Katheria, MD, Principal Investigator, Sharp HealthCare
  • Overall Contact(s)
    • Anup Katheria, MD, 8589394170, anup.katheria@sharp.com

References

Katheria A, Arnell K, Brown M, Hassen K, Maldonado M, Rich W, Finer N. A pilot randomized controlled trial of EKG for neonatal resuscitation. PLoS One. 2017 Nov 3;12(11):e0187730. doi: 10.1371/journal.pone.0187730. eCollection 2017.

Johnson PA, Schmölzer GM. Heart Rate Assessment during Neonatal Resuscitation. Healthcare (Basel). 2020 Feb 23;8(1). pii: E43. doi: 10.3390/healthcare8010043. Review.

Neonatal Resuscitation. Vol. 7th edition. 2016, Elk Grove Village, IL: American Academy of Pediatrics.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.