Time to Accurate Heart Rate on Neonatal Outcomes

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Time to Accurate Heart Rate on Neonatal Outcomes

Conditions
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Premature Infant, Extremely Low Birth Weight, Extreme Prematurity

Intervention / Treatment
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* Device: iRes Warmer with ResusView
* Other: iRes Warmer without ResusView


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 23 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: iRes Warmer with ResusView<br>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<br>* Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age<br>* Other names: Panda Bed with ECG Feature;|
| Active Comparator: iRes Warmer without ResusView<br>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<br>* Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age<br>* Other names: Standard of Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to heart rate display in iRes Warmer with Resusview | Measure time from birth to heart rate displayed on monitor following lead placement | Birth to 10 minutes of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first change in Fraction of inspired oxygen | Measure time from birth to first increase or decrease in fraction of inspired oxygen from ECG lead placement | Birth to 10 minutes of life | 
| Time to first change in airway pressure | Measure time from birth to first increase or decrease in airway pressure from ECG lead placement | Birth to 10 minutes of life | 
| Time to initiation of Positive Pressure Ventilation (PPV) | Measure time from birth to start of PPV following first heart rate display | Birth to 10 minutes of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electrocardiogram, Neonatal Resuscitation, resuscitation of premature infants