SURV1VE-trial CC+SI vs 3:1C:V results published
What is the SURV1VE-trial?
Neonatal resuscitation guidelines recommend a 3:1 Compression:Ventilation (3:1 C:V) ratio. over the last decace we studies ad different approach combining continuous chest compression (CC) superimposed by a high distending pressure (what we called sustained inflation = SI).
CC+SI compared to 3:1 C:V significantly reduced time to return of spontaneous circulation (ROSC) in animal studies and a phase 1 trial in preterm infants <32 weeks’ gestation.
Methods
The SURV1VE-Trial was an international, multi-center, prospective, cluster cross-over randomized trial in asphyxiated newborn infants at birth at four sites.
We hypothesized that in newborn infants requiring CC in the delivery room CC+SI compared to 3:1 C:V will decreases time to ROSC. Term infants and preterm infants >28 weeks’ gestation were eligible. Hospitals were randomized to CC+SI or 3:1 C:V for 12 months then crossed over for an additional year to the other intervention (12 months).
The primary outcome was time to ROSC.
A sample size of 218 infants (109/group) were sufficient to detect a clinically important 33% reduction (282 vs. 420sec of CC) in time to ROSC. Analysis was intention-to-treat.
Total number of infants:
Patient recruitment occurred between Oct 19, 2017 and Sep 22, 2022 and included 29 infants (12 with CC+SI and 15 with 3:1 C:V, two (one per group) declined consent).
Yes, the number is much smaller then the targeted sample size, due to several institutional review boards postponing approval until the 1st interim safety analysis, challange to obtain clinical trials insurance (took 3.5 years to obtain it), and COVID-19 pandemic.
Primary outcome: Time to ROSC:
The median (IQR) time to ROSC with CC+SI was 90 (60-270)sec and with 3:1 C:V 615 (174-780)sec.
Safety outcome
Mortality: 2/11 (18%) with CC+SI vs 8/14 (57%) with 3:1 C:V
Intraventricular hemorrhage: In the CC+SI group, 1/11 (9%) and 2/14 (17%) patients with 3:1 C:V.
Air leaks: 1/11 (9%) with CC+SI, and 2/14 (16%) in the 3:1 C:V group.
What are the next steps?
We need to do a large randomized trial, which again will be a cluster trial, and we hope with all the knowledge gained in doing the last one, it will go smoother.
If you are interested in learning more, sonnet with us on schmolze@ualberta.ca.
So staty tuned for SURV1VE-2
What’s Known on This Subject
· 3:1 Compression:Ventilation ratio is recommended during neonatal cardiopulmonary resuscitation
· the optimal compression and ventilation approach is unknow.
· Continuous chest compression superimposed by a sustained inflation significantly reduced time to return of spontaneous circulation in animal studies and a pilot-trial in preterm infants <32 weeks’ gestation compared to 3:1 Compression:Ventilation
What This Study Adds
· There was no statistical significant difference in time to return of spontaneous circulation between continuous chest compression superimposed by a sustained inflation and 3:1 Compression:Ventilation
· There was no statistical significant difference in survival between continuous chest compression superimposed by a sustained inflation and 3:1 Compression:Ventilation
· The trial suffered inherent difficulties as several institutional review boards postponed their approval until the 1stinterim safety analysis and obtaining clinical trials insurance for a trial addressing neonatal cardiopulmonary resuscitation was nearly impossible.
How this study might affect research, practice or policy
· A larger randomized trial comparing continuous chest compression superimposed by a sustained inflation and 3:1 Compression:Ventilation is warranted before this technique should be used in the delivery room.
Thank you
I would like to express my appreciation to the parents who consent to have their child participate in the trial, the funding agencies, and all the staff at all participating centres, without all of you, this research would have been impossible.
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