Time to Accurate Heart Rate on Neonatal Outcomes

Sharp HealthCare42 enrolled

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Premature Infant Extremely Low Birth Weight Extreme Prematurity

Interventions

iRes Warmer with ResusViewDEVICE

Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age

iRes Warmer without ResusViewOTHER

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

Eligibility

Sex: ALLMin age: 23 WeeksMax age: 32 Weeks

Medical Language ↔ Plain English

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

Locations (1)

Sharp Mary Birch Hospital for Women and Newborns

San Diego, California, United States

Outcomes

Primary Outcomes

Time to Heart Rate Display in iRes Warmer With Resusview

Measure time from birth to heart rate displayed on monitor following lead placement

Time frame: Birth to 10 minutes of life

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Birth to 10 minutes of life

Data from ClinicalTrials.gov

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