Cardiac ArrestSUR1VE-2NCT06577818
Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns
A study testing CC+SI (Chest compression during sustained inflation) and 3:1 C:V (3:1 Compression:Ventilation ratio) in people with Cardiac Arrest, run by University of Alberta at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 40 minutes
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- CC+SI (Chest compression during sustained inflation) and 3:1 C:V (3:1 Compression:Ventilation ratio)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 554 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2027to 1 Jul 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 40 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborns with gestational age born between 28 to 43 weeks based on best available obstetrical estimate
- Newborns designated to receive full resuscitation, i.e., parental request or pre-determined decision to provide only comfort care at birth
- No known major congenital or chromosomal malformation. All newborns who meet inclusion criteria will be enrolled as the centres agreed to change their local hospital policy during the trial. The inclusion criteria are designed to be pragmatic and provide useful knowledge translation for most of the patient population in the future.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Sustained Inflation and Chest Compression Versus 3:1 Chest Compression to Ventilation Ratio During Cardiopulmonary Resuscitation of Asphyxiated Newborns - a Multi-centre, International Cluster Randomized Control Trial
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.
Read more
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.
- Conditions
- Cardiac Arrest
- Being tested
- CC+SI (Chest compression during sustained inflation), 3:1 C:V (3:1 Compression:Ventilation ratio)
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CC+SI (Chest compression during sustained inflation)Procedure or surgery
CC+SI (Chest compression during sustained inflation)
3:1 C:V (3:1 Compression:Ventilation ratio)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: CC+SI (Chest compression during sustained inflation) |
| 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. Receives: Procedure: 3:1 C:V (3:1 Compression:Ventilation ratio) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal mortality
All mortality within the initial hospital stay
Measured: 0-40 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start1 Jan 2027 (estimated)
- Primary completion1 Jul 2031 (estimated)
- Study completion1 Jul 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 554 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Georg Schmolzer, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06577818
- Sponsor's protocol ID
- Pro00145624
- Acronym
- SUR1VE-2
- Status last verified
- Apr 2026
- First submitted
- 27 Aug 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Inflation and Chest Compression Versus 3:1 Chest Compression to Ventilation Ratio During Cardiopulmonary Resuscitation of Asphyxiated Newborns - a Multi-centre, International Cluster Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06577818
- Acronym / sponsor ID
- SUR1VE-2 / Pro00145624
- Conditions
- Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 554 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- 1 Jul 2031 (estimated)
- Study completion
- 1 Jul 2033 (estimated)
- First posted
- 29 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CC+SI (Chest compression during sustained inflation) | Experimental | Procedure: CC+SI (Chest compression during sustained inflation)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. |
| 3:1 C:V (3:1 Compression:Ventilation ratio) | Active comparator | Procedure: 3:1 C:V (3:1 Compression:Ventilation ratio)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. |
Who may qualify
- Ages
- Up to 40 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Newborns with gestational age born between 28 to 43 weeks based on best available obstetrical estimate
- Newborns designated to receive full resuscitation, i.e., parental request or pre-determined decision to provide only comfort care at birth
- No known major congenital or chromosomal malformation. All newborns who meet inclusion criteria will be enrolled as the centres agreed to change their local hospital policy during the trial. The inclusion criteria are designed to be pragmatic and provide useful knowledge translation for most of the patient population in the future.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CC+SI (Chest compression during sustained inflation)CC+SI (Chest compression during sustained inflation) | Procedure or surgery | CC+SI (Chest compression during sustained inflation) |
| 3:1 C:V (3:1 Compression:Ventilation ratio)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. | Procedure or surgery | 3:1 C:V (3:1 Compression:Ventilation ratio) |
Primary outcome
Neonatal mortality
Time frame: 0-40 days after birth
All mortality within the initial hospital stay
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Arrest
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Recruiting
The VENTOR Clinical Study
Cardiac Arrest (CA)
RecruitingObservational study
Physiology-directed Epinephrine Dosing in Pediatric Cardiac Arrest
Cardiac Arrest (CA)
RecruitingObservational study
Quality of Pediatric Resuscitation in a Multicenter Collaborative
Cardiac Arrest, Cardiopulmonary Arrest
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Georg Schmolzer principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CC+SI (Chest compression during sustained inflation) and 3:1 C:V (3:1 Compression:Ventilation ratio) in people with Cardiac Arrest, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Fray (+1 (780) 613-5237, caroline.fray@albertahealthservices.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal mortality (time frame: 0-40 days after birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.