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

Sharp HealthCare

Status: Completed

Conditions: Extremely Low Birth Weight; Premature Infant; Extreme Prematurity

Treatments: Other: iRes Warmer without ResusView; Device: iRes Warmer with ResusView

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04587934

GE-EKG

Details and patient eligibility

About

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).

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 23 to 32 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

iRes Warmer with ResusView

Experimental group

Description:

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.

Treatment:

Device: iRes Warmer with ResusView

iRes Warmer without ResusView

Active Comparator group

Description:

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.

Treatment:

Other: iRes Warmer without ResusView