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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best method for performing chest compressions on newborns experiencing cardiac arrest immediately after birth. It compares a new technique, CC+SI (chest compression during sustained inflation), with the standard 3:1 compression-to-ventilation ratio. The researchers aim to determine if the new method reduces deaths during the initial hospital stay. Newborns between 28 to 43 weeks who require full resuscitation and have no major birth defects can participate in this study.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance newborn resuscitation techniques.

Will I have to stop taking my current medications?

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

What prior data suggests that these chest compression techniques are safe for newborns?

Research has shown that a new chest compression method, called CC+SI, might aid in reviving newborns. CC+SI involves pressing on the chest while providing a steady breath of air. A few studies have tested this technique, and results suggest it could improve survival and help the heart recover its normal rhythm faster than the standard 3:1 C:V method. These studies did not find any major safety issues, indicating the treatment has generally been safe. However, effects can vary, and further research is underway to confirm these findings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative techniques to improve CPR for newborns experiencing cardiac arrest. The trial compares the standard 3:1 compression-to-ventilation ratio with a new method called CC+SI, which involves performing chest compressions during sustained inflations. This new approach allows continuous chest compressions while simultaneously delivering breaths, which could potentially enhance blood flow and oxygen delivery more effectively. Researchers hope to find out if this technique leads to quicker return of spontaneous circulation compared to the current standard of care.

What evidence suggests that these chest compression techniques could be effective for cardiac arrest in newborns?

This trial will compare two chest compression techniques for cardiac arrest in newborns: the CC+SI technique and the 3:1 C:V method. Research suggests that the CC+SI technique, which participants in this trial may receive, might be more effective than the current 3:1 C:V method. Studies have shown that CC+SI can help a newborn's heart start beating on its own more quickly. This technique might also improve survival rates and enhance breathing and heart function. One study indicated that using CC+SI could potentially lead to fewer infant deaths compared to the 3:1 C:V method. Overall, CC+SI shows promise as a helpful CPR method for newborns. ^{1 2 3 4 6}

Who Is on the Research Team?

Georg Schmolzer

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7913022/

Is Chest Compression Superimposed with Sustained ... 14. Conclusions. CC + SI reduces time to ROSC, improves mortality, and improves respiratory and hemodynamic parameters compared to 3:1 C:V ratio during ...

2. ahajournals.org ahajournals.org/doi/10.1161/circ.148.suppl_1.279

Abstract 279: Sustained Inflation and Chest Compression ... CC+SI resulted in a reduction in time to ROSC. There was a trend towards higher survival rates with CC+SI.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT02858583

SI + CC Versus 3:1 C:V Ratio During Neonatal CPR Secondary objectives: To examine i) if CC during sustained inflation will improve short- and long-term outcomes in preterm and term newborns, and ii) the value ...

4. mdpi.com mdpi.com/2227-9067/12/2/230

Chest Compression Superimposed with Sustained Inflation ... The use of CC + SI during neonatal CPR could result in 182 fewer per 1000 (from 351 fewer to 311 more) infant deaths. The pooled data suggested a significant ...

5. fn.bmj.com fn.bmj.com/content/109/4/428

A cluster randomised controlled trial A sustained inflation (CC+SI) compared with a 3:1 compression:ventilation (3:1 C:V) ratio decreases time to return of spontaneous circulation (ROSC).

6. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-019-3240-8

The SURV1VE trial—sustained inflation and chest ... The current neonatal resuscitation guidelines recommend using a coordinated 3:1 compression-to-ventilation (C:V) ratio (CC at a rate of 90/min ...