Time to Accurate Heart Rate on Neonatal Outcomes
- Conditions
- Extreme PrematurityExtremely Low Birth WeightPremature Infant
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- 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
Related Research Topics
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Trial Locations
- Locations (1)
Sharp Mary Birch Hospital for Women and Newborns
🇺🇸San Diego, California, United States
Sharp Mary Birch Hospital for Women and Newborns🇺🇸San Diego, California, United States