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Not yet recruitingNCT06577818SUR1VE-2Updated May 4, 2026

Sustained Inflation and Chest Compression vs 3:1 C:V Ratio in Asphyxiated Newborns

An interventional study of CC+SI (Chest compression during sustained inflation) and 3:1 C:V (3:1 Compression:Ventilation ratio) in Cardiac Arrest, sponsored by University of Alberta. Not yet recruiting at 1 site in Canada. Open to participants aged Up to 40 Minutes. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by University of Alberta · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
554
Allocation
Randomized
Ages
Up to 40 Minutes
Sex
All
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Study 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.

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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Conditions studied

  • Cardiac Arrest

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03

In context

Heart Arrest

966 studies on the registry are indexed under Heart Arrest; 227 are open to participants now.

This study's planned enrollment of 554 is above the median of 100 across 557 interventional studies indexed under Heart Arrest.

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Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 40 Minutes
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion 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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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
554 participants (estimated)

Study arms

  • Experimental
    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.

    Procedure: CC+SI (Chest compression during sustained inflation)

  • Active comparator
    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: 3:1 C:V (3:1 Compression:Ventilation ratio)

Interventions

  • ProcedureCC+SI (Chest compression during sustained inflation)

    CC+SI (Chest compression during sustained inflation)

  • Procedure3:1 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.

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What researchers measure

Primary outcomes

  1. Neonatal mortality

    All mortality within the initial hospital stay

    Time frame: 0-40 days after birth

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Study locations

1 site
  • Royal Alexandra Hospital
    Edmonton, Canada
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06577818
Lead sponsor
University of Alberta
Responsible party
Sponsor
First posted
Aug 29, 2024
Start date
Sep 1, 2026 (estimated)
Primary completion
Jul 1, 2031 (estimated)
Completion
Jul 1, 2033 (estimated)
Last update
May 4, 2026

Study contacts

Caroline Fray
Contact
caroline.fray@albertahealthservices.ca
+1 (780) 613-5237‬
Georg Schmolzer
principal investigator · University of Alberta

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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