Trial Outcomes & Findings for Time to Accurate Heart Rate on Neonatal Outcomes (NCT NCT04587934)
NCT ID: NCT04587934
Last Updated: 2024-01-10
Results Overview
Measure time from birth to heart rate displayed on monitor following lead placement
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Birth to 10 minutes of life
Results posted on
2024-01-10
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
23
|
|
Overall Study
COMPLETED
|
19
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
iRes Warmer With ResusView
n=19 Participants
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
|
iRes Warmer Without ResusView
n=23 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
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 weeks gestational age at birth
STANDARD_DEVIATION 3 • n=19 Participants
|
28 weeks gestational age at birth
STANDARD_DEVIATION 3 • n=23 Participants
|
28 weeks gestational age at birth
STANDARD_DEVIATION 3 • n=42 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=19 Participants
|
8 Participants
n=23 Participants
|
17 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=19 Participants
|
15 Participants
n=23 Participants
|
25 Participants
n=42 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
19 Participants
n=19 Participants
|
23 Participants
n=23 Participants
|
42 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Birth to 10 minutes of lifePopulation: All with available electrocardiogram data and prenatal consent
Measure time from birth to heart rate displayed on monitor following lead placement
Outcome measures
| Measure |
iRes Warmer With ResusView
n=19 Participants
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
|
iRes Warmer Without ResusView
n=23 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
|
|---|---|---|
|
Time to Heart Rate Display in iRes Warmer With Resusview
|
16 seconds from time of birth
Standard Deviation 11
|
50 seconds from time of birth
Standard Deviation 50
|
SECONDARY outcome
Timeframe: Birth to 10 minutes of lifePopulation: all subject with available electrocardiogram and fraction of inspired oxygen with consent prior to birth
Measure time from birth to first increase or decrease in fraction of inspired oxygen from ECG lead placement
Outcome measures
| Measure |
iRes Warmer With ResusView
n=19 Participants
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
|
iRes Warmer Without ResusView
n=23 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
|
|---|---|---|
|
Time to First Change in Fraction of Inspired Oxygen
|
160 seconds from time of birth
Standard Deviation 140
|
175 seconds from time of birth
Standard Deviation 79
|
SECONDARY outcome
Timeframe: Birth to 10 minutes of lifeMeasure time from birth to first increase or decrease in airway pressure from ECG lead placement
Outcome measures
| Measure |
iRes Warmer With ResusView
n=19 Participants
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
|
iRes Warmer Without ResusView
n=23 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
|
|---|---|---|
|
Time to First Change in Airway Pressure
|
215 seconds from time of birth
Standard Deviation 204
|
100 seconds from time of birth
Standard Deviation 69
|
SECONDARY outcome
Timeframe: Birth to 10 minutes of lifePopulation: all with available electrocardiogram data and resuscitation intervention details
Measure time from birth to start of PPV following first heart rate display
Outcome measures
| Measure |
iRes Warmer With ResusView
n=19 Participants
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
|
iRes Warmer Without ResusView
n=23 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
|
|---|---|---|
|
Time to Initiation of Positive Pressure Ventilation (PPV)
|
58 seconds from time of birth
Standard Deviation 22
|
139 seconds from time of birth
Standard Deviation 79
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Birth to 10 minutes of lifePopulation: all with electrocardiogram lead placement during resuscitation
Measure time from birth to application of Electrocardiogram electrodes from time of birth
Outcome measures
| Measure |
iRes Warmer With ResusView
n=19 Participants
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
|
iRes Warmer Without ResusView
n=23 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
|
|---|---|---|
|
Time of Electrode Placement
|
96 seconds from time of birth
Standard Deviation 24
|
112 seconds from time of birth
Standard Deviation 36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Birth to 10 minutes of lifePopulation: all with electrocardiogram lead placement
Identify if a cardiac rhythm is recognized by Electrocardiogram monitor algorithm and displays a waveform during resuscitation (Yes/No)
Outcome measures
| Measure |
iRes Warmer With ResusView
n=19 Participants
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
|
iRes Warmer Without ResusView
n=23 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
|
|---|---|---|
|
EKG Waveform Displayed by Rapid EKG Algorithm During Resuscitation
|
19 Participants
|
23 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Birth to 10 minutes of lifePopulation: all with electrocardiogram data
Measure at what time the Warmer displays the baby's cardiac rhythm
Outcome measures
| Measure |
iRes Warmer With ResusView
n=19 Participants
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
|
iRes Warmer Without ResusView
n=23 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
|
|---|---|---|
|
Time to Rhythm Recognition
|
111 seconds from time of EKG lead placement
Standard Deviation 28
|
161 seconds from time of EKG lead placement
Standard Deviation 56
|
Adverse Events
iRes Warmer With ResusView
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
iRes Warmer Without ResusView
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place