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
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