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Newborn infants who require cardiopulmonary resuscitation at birth receive chest compression using a 3-Compression to 1-Ventilation (3:1 C:V) ratio. However, the optimal chest compression technique during cardiopulmonary resuscitation is uncertain and identified as a critical gap in evidence.
The International Consensus Statement advises to use the 3:1 C:V ratio based on animal studies, and states that there are no clinical trials to support this approach and called for more research. There continues to be uncertainty about the optimal chest compression technique during cardiopulmonary resuscitation.
This trial will compare if in newborn infants with cardiac arrest in the delivery room does providing CC+SI (a new chest compression technique) compared to 3:1 C:V decreases the incidence of all mortality within the initial hospital stay.
This will be a multi-centre international cluster randomized trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CC+SI (Chest compression during sustained inflation) | Experimental | CC+SI Group (Intervention group): Newborns randomized to "CC+SI" will receive CPR with a SI using a peak inflation pressure (PIP) of 30cmH2O while receiving CC. The PIP was chosen based on our animal studies and two previous clinical trials. CC will be performed at a rate of minimum 90/min. Each SI will be delivered for duration of 30sec with a 1 sec pause between the next SI for 30sec is started while CCs are continued. After 2x30sec CC+SI (total of 60sec), Heart rate (HR) will be assessed: A HR <60/min means CC+SI is continued for another 60sec (2x30sec CC+SI), followed by another HR assessment. If HR >60/min, CC are stopped (current standard of care). CC+SI will continued until ROSC. |
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| 3:1 C:V (3:1 Compression:Ventilation ratio) | Active Comparator | 3:1 C:V Group (Control group - Standard of Care): Newborns randomized to "3:1 C:V" will receive a CC rate of 90/min and 30 ventilations/min as per current resuscitation guidelines. The PIP used for the 30 inflations will also be 30cmH2O) as per current resuscitation guidelines. Every 60sec, a HR assessment as per neonatal guidelines will be performed to assess if HR is <60/min - continue CC or >60/min - stop CC (current standard of care). 3:1 C:V will be continued until ROSC. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CC+SI (Chest compression during sustained inflation) | Procedure | CC+SI (Chest compression during sustained inflation) |
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| Measure | Description | Time Frame |
|---|---|---|
| Neonatal mortality | All mortality within the initial hospital stay | 0-40 days after birth |
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Inclusion Criteria:
Exclusion Criteria:
- Newborns born outside of study centers and transported to centers after delivery.
Sex, race, and ethnicity are not part of the exclusion criteria for this trial, and as such it should represent the combined demographics of all centers involved.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Fray | Contact | +1 (780) 613-5237‬ | caroline.fray@albertahealthservices.ca |
| Name | Affiliation | Role |
|---|---|---|
| Georg Schmolzer | University of Alberta | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Alexandra Hospital | Edmonton | Canada |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 3:1 C:V (3:1 Compression:Ventilation ratio) | Procedure | 3:1 C:V Group (Control group - Standard of Care): Newborns randomized to "3:1 C:V" will receive a CC rate of 90/min and 30 ventilations/min as per current resuscitation guidelines. The PIP used for the 30 inflations will also be 30cmH2O) as per current resuscitation guidelines. Every 60sec, a HR assessment as per neonatal guidelines will be performed to assess if HR is <60/min - continue CC or >60/min - stop CC (current standard of care). 3:1 C:V will be continued until ROSC. |
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