Time to Accurate Heart Rate on Neonatal Outcomes

Premature Infant Clinical Trial

— GE-EKG  

Official title:

Time to Accurate Heart Rate on Neonatal Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04587934
• Other study ID #: GE-EKG
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: December 10, 2021

Study information

• Verified date: December 2023
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 10, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 32 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Extreme Prematurity
• Extremely Low Birth Weight
• Premature Infant

Intervention

Device:
• 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

Other:
• iRes Warmer without ResusView
Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age

Locations

Country	Name	City	State
United States	Sharp Mary Birch Hospital for Women and Newborns	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Sharp HealthCare	GE Healthcare, Sharp Mary Birch Hospital for Women & Newborns

Country where clinical trial is conducted

United States, 

References & Publications (3)

Johnson PA, Schmolzer GM. Heart Rate Assessment during Neonatal Resuscitation. Healthcare (Basel). 2020 Feb 23;8(1):43. doi: 10.3390/healthcare8010043. — View Citation

Katheria A, Arnell K, Brown M, Hassen K, Maldonado M, Rich W, Finer N. A pilot randomized controlled trial of EKG for neonatal resuscitation. PLoS One. 2017 Nov 3;12(11):e0187730. doi: 10.1371/journal.pone.0187730. eCollection 2017. — View Citation

Neonatal Resuscitation. Vol. 7th edition. 2016, Elk Grove Village, IL: American Academy of Pediatrics.

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time of Electrode Placement	Measure time from birth to application of Electrocardiogram electrodes from time of birth	Birth to 10 minutes of life
Other	EKG Waveform Displayed by Rapid EKG Algorithm During Resuscitation	Identify if a cardiac rhythm is recognized by Electrocardiogram monitor algorithm and displays a waveform during resuscitation (Yes/No)	Birth to 10 minutes of life
Other	Time to Rhythm Recognition	Measure at what time the Warmer displays the baby's cardiac rhythm	Birth to 10 minutes of life
Primary	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	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
Secondary	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
Secondary	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