Time to Accurate Heart Rate on Neonatal Outcomes

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04587934

Acronym

GE-EKG

Enrollment

Registered

2020-10-14

Start date

2021-02-01

Completion date

2021-12-10

Last updated

2024-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Extremely Low Birth Weight, Extreme Prematurity, Premature Infant

Keywords

electrocardiogram, Neonatal Resuscitation, resuscitation of premature infants

Brief summary

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

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

DEVICEiRes 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

OTHERiRes Warmer without ResusView

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

23 Weeks to 32 Weeks

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

Design outcomes

Primary

Measure	Time frame	Description
Time to Heart Rate Display in iRes Warmer With Resusview	Birth to 10 minutes of life	Measure time from birth to heart rate displayed on monitor following lead placement

Secondary

Measure	Time frame	Description
Time to First Change in Fraction of Inspired Oxygen	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	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)	Birth to 10 minutes of life	Measure time from birth to start of PPV following first heart rate display

Other

Measure	Time frame	Description
EKG Waveform Displayed by Rapid EKG Algorithm During Resuscitation	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)
Time to Rhythm Recognition	Birth to 10 minutes of life	Measure at what time the Warmer displays the baby's cardiac rhythm
Time of Electrode Placement	Birth to 10 minutes of life	Measure time from birth to application of Electrocardiogram electrodes from time of birth

Countries

United States

Participant flow

Recruitment details

Pregnant women who are dated by their earliest ultrasound scan or last menstrual period at 230/7 to 326/7 weeks of gestational age were identified, recruited, and consented from the labor and delivery floor or perinatal special care unit at Sharp Mary Birch Hospital Women & Newborns from February 2021 through June 2021.

Participants by arm

Arm	Count
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. 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	19
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. iRes Warmer without ResusView: Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age	23
Total	42

Baseline characteristics

Characteristic	iRes Warmer Without ResusView	Total	iRes Warmer With ResusView
Age, Continuous	28 weeks gestational age at birth STANDARD_DEVIATION 3	28 weeks gestational age at birth STANDARD_DEVIATION 3	28 weeks gestational age at birth STANDARD_DEVIATION 3
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United States	23 Participants	42 Participants	19 Participants
Sex: Female, Male Female	8 Participants	17 Participants	9 Participants
Sex: Female, Male Male	15 Participants	25 Participants	10 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 19	0 / 23
other Total, other adverse events	0 / 19	0 / 23
serious Total, serious adverse events	0 / 19	0 / 23