Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123, United States
NCT Number: NCT04587934
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).
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Notify Me23 week–32 week
All sexes
Interventional
Not applicable
San Diego, California, 92123, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 names: Panda Bed with ECG Feature
Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age
Other names: Standard of Care
Time frame: Birth to 10 minutes of life
Measure time from birth to heart rate displayed on monitor following lead placement
Time frame: 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 frame: Birth to 10 minutes of life
Measure time from birth to first increase or decrease in airway pressure from ECG lead placement
Time frame: Birth to 10 minutes of life
Measure time from birth to start of PPV following first heart rate display
Time frame: Birth to 10 minutes of life
Measure time from birth to application of Electrocardiogram electrodes from time of birth
Time frame: 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 frame: Birth to 10 minutes of life
Measure at what time the Warmer displays the baby's cardiac rhythm
Sharp HealthCare
Other
Acronym: GE-EKG
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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