Premature Infant Clinical Trial
— GE-EKGOfficial title:
Time to Accurate Heart Rate on Neonatal Outcomes
Verified date | December 2023 |
Source | Sharp HealthCare |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
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 |
Country | Name | City | State |
---|---|---|---|
United States | Sharp Mary Birch Hospital for Women and Newborns | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Sharp HealthCare | GE Healthcare, Sharp Mary Birch Hospital for Women & Newborns |
United States,
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.
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 |
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