Chest Compression Techniques for Cardiac Arrest in Newborns

(SUR1VE-2 Trial)

Overseen By Caroline Fray

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Born outside study centers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Immediate intervention at birth

554 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of the treatment 3:1 C:V, CC+SI for cardiac arrest in newborns?

Research shows that combining chest compressions with sustained inflations (CC+SI) can improve outcomes in newborn resuscitation by reducing the time to return of spontaneous circulation and improving oxygen delivery, without increasing injury compared to the standard 3:1 compression:ventilation ratio. ^{1 2 3 4 5}

Is chest compression safe for newborns during resuscitation?

Research shows that combining chest compressions with sustained inflation (CC+SI) in newborns does not increase lung or brain injury markers compared to the standard 3:1 compression-to-ventilation ratio, suggesting it is generally safe. ^{1 3 4 6 7}

How does the 3:1 C:V, CC+SI treatment for cardiac arrest in newborns differ from other treatments?

The 3:1 C:V, CC+SI treatment combines chest compressions with sustained inflation, which has been shown to improve outcomes by reducing the time to return of spontaneous circulation and improving oxygen delivery without increasing injury markers, compared to the standard 3:1 compression to ventilation ratio. ^{1 3 8 9 10}

What is the purpose of this 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. 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 mortality at hospital discharge. This will be a multi-centre international cluster randomized trial.

Research Team

Georg Schmolzer

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for newborn infants who experience cardiac arrest in the delivery room and require cardiopulmonary resuscitation. The eligibility criteria are not fully listed, but typically include specific health conditions of the infant.

Inclusion Criteria

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.

My baby was born between 28 to 43 weeks of pregnancy.

My newborn will receive all necessary life-saving measures.

Exclusion Criteria

Newborns born outside of study centers and transported to centers after delivery

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Newborns receive cardiopulmonary resuscitation using either CC+SI or 3:1 C:V technique

Immediate intervention at birth

Follow-up

Participants are monitored for mortality until hospital discharge

0-40 days

Treatment Details

Interventions

• 3:1 C:V
• CC+SI

Trial Overview The study is testing two different techniques of chest compressions during cardiopulmonary resuscitation: CC+SI (Chest compression with sustained inflation) versus the standard 3:1 Compression to Ventilation ratio. It aims to determine which method better reduces mortality at hospital discharge.

Participant Groups

Group I: CC+SI (Chest compression during sustained inflation) Experimental Treatment 1 Intervention

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.

Group II: 3:1 C:V (3:1 Compression:Ventilation ratio) Active Control 1 Intervention

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 Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Chest Compressions During Sustained Inflation During Cardiopulmonary Resuscitation in Newborn Infants Translating Evidence From Animal Studies to the Bedside. [2020]

2. England pubmed.ncbi.nlm.nih.gov

A comparison between the two methods of chest compression in infant and neonatal resuscitation. A review according to 2010 CPR guidelines. [2018]

3. Poland pubmed.ncbi.nlm.nih.gov

Comparison of two infant chest compression techniques during simulated newborn cardiopulmonary resuscitation performed by a single rescuer: A randomized, crossover multicenter trial. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Chest compressions in newborn animal models: A review. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Chest Compressions during Sustained Inflations Improve Recovery When Compared to a 3:1 Compression:Ventilation Ratio during Cardiopulmonary Resuscitation in a Neonatal Porcine Model of Asphyxia. [2018]

6. England pubmed.ncbi.nlm.nih.gov

The SURV1VE trial-sustained inflation and chest compression versus 3:1 chest compression-to-ventilation ratio during cardiopulmonary resuscitation of asphyxiated newborns: study protocol for a cluster randomized controlled trial. [2020]

7. Ireland pubmed.ncbi.nlm.nih.gov

Does a more "physiological" infant manikin design effect chest compression quality and create a potential for thoracic over-compression during simulated infant CPR? [2019]

8. England pubmed.ncbi.nlm.nih.gov

A review of approaches to optimise chest compressions in the resuscitation of asphyxiated newborns. [2016]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Chest Compressions in the Delivery Room. [2020]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Effect of Different Respiratory Modes on Return of Spontaneous Circulation in a Newborn Piglet Model of Hypoxic Cardiac Arrest. [2016]