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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
| Sharp Mary Birch Hospital for Women & Newborns | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iRes Warmer with ResusView | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iRes Warmer with ResusView | Device | Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Time to First Change in Airway Pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Time of Electrode Placement | Measure time from birth to application of Electrocardiogram electrodes from time of birth | Birth to 10 minutes of life |
| EKG Waveform Displayed by Rapid EKG Algorithm During Resuscitation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anup Katheria, MD | Sharp HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Mary Birch Hospital for Women and Newborns | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29099872 | Background | 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. | |
| 32102255 | Background | Johnson PA, Schmolzer GM. Heart Rate Assessment during Neonatal Resuscitation. Healthcare (Basel). 2020 Feb 23;8(1):43. doi: 10.3390/healthcare8010043. |
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Individual participant data, particularly data that underlie the results reported in this article after deidentification will be available with other researchers, including data dictionaries for meta-analysis.
Beginning 6 months and ending 36 months following article publication
Data and publication are available at clinicaltrials.gov
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Pregnant women who are dated by their earliest ultrasound scan or last menstrual period at 230/7 to 326/7 weeks of gestational age were identified, recruited, and consented from the labor and delivery floor or perinatal special care unit at Sharp Mary Birch Hospital Women & Newborns from February 2021 through June 2021.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 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 |
| FG001 | 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. iRes Warmer without ResusView: Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
all consented and enrolled in study
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Heart Rate Display in iRes Warmer With Resusview | Measure time from birth to heart rate displayed on monitor following lead placement | All with available electrocardiogram data and prenatal consent | Posted | Mean | Standard Deviation | seconds from time of birth | Birth to 10 minutes of life |
|
birth to 10 minutes of life
Research/clinical staff collected information about resuscitation interventions for each participant at the time of birth
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anup Katheria | Sharp Healthcare | 858-939-4170 | Anup.Katheria@sharp.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 16, 2021 | Nov 20, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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|
| iRes Warmer without ResusView | Other | Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age |
|
|
Measure time from birth to first increase or decrease in airway pressure from ECG lead placement
| Birth to 10 minutes of life |
| 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 |
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 |
| Time to Rhythm Recognition | Measure at what time the Warmer displays the baby's cardiac rhythm | Birth to 10 minutes of life |
| Background | Neonatal Resuscitation. Vol. 7th edition. 2016, Elk Grove Village, IL: American Academy of Pediatrics. |
| 34715091 | Derived | Katheria AC, Morales A, Shashank S, Rich WD, Finer NN. A Pilot Randomized Trial of Heart Rate Monitoring Using Conventional Versus a New Electrocardiogram Algorithm during Neonatal Resuscitation at Birth. J Pediatr. 2022 Mar;242:245-247.e1. doi: 10.1016/j.jpeds.2021.10.037. Epub 2021 Oct 27. |
| BG001 | 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. iRes Warmer without ResusView: Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age |
| BG002 | Total | Total of all reporting groups |
| weeks gestational age at birth |
|
| Sex: Female, Male | Sex assigned at birth | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
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. iRes Warmer without ResusView: Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age |
|
|
| 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 | all subject with available electrocardiogram and fraction of inspired oxygen with consent prior to birth | Posted | Mean | Standard Deviation | seconds from time of birth | 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 | Posted | Mean | Standard Deviation | seconds from time of birth | 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 | all with available electrocardiogram data and resuscitation intervention details | Posted | Mean | Standard Deviation | seconds from time of birth | Birth to 10 minutes of life |
|
|
|
| Other Pre-specified | Time of Electrode Placement | Measure time from birth to application of Electrocardiogram electrodes from time of birth | all with electrocardiogram lead placement during resuscitation | Posted | Mean | Standard Deviation | seconds from time of birth | Birth to 10 minutes of life |
|
|
|
| Other Pre-specified | 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) | all with electrocardiogram lead placement | Posted | Count of Participants | Participants | Birth to 10 minutes of life |
|
|
|
| Other Pre-specified | Time to Rhythm Recognition | Measure at what time the Warmer displays the baby's cardiac rhythm | all with electrocardiogram data | Posted | Mean | Standard Deviation | seconds from time of EKG lead placement | Birth to 10 minutes of life |
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 0 |
| 19 |
| EG001 | 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. iRes Warmer without ResusView: Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age | 0 | 23 | 0 | 23 | 0 | 23 |
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| D000091642 | Urogenital Diseases |