Time to Accurate Heart Rate on Neonatal Outcomes

Not Applicable

Completed

• Conditions: Extreme Prematurity; Extremely Low Birth Weight; Premature Infant
• Interventions: Device: iRes Warmer with ResusView; Other: iRes Warmer without ResusView

• Registration Number: NCT04587934
• Lead Sponsor: Sharp HealthCare

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.

Study Timeline

• Study First Submitted: 2020-10-02
• Study First Submitted QC: 2020-10-08
• Study First Posted: 2020-10-14
• Study Start: 2021-02-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-12-10
• Results First Submitted: 2023-11-20
• Status Verified: 2023-12
• Results First Submitted QC: 2023-12-19
• Last Update Submitted: 2023-12-19
• Results First Posted: 2024-01-10
• Last Update Posted: 2024-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
iRes Warmer with ResusView	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 without ResusView	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Sharp Mary Birch Hospital for Women and Newborns; 🇺🇸 San Diego, California, United States