Starting the conversation for the next SURV1VE-trial
While the SURV1VE-trial is currently under peer-review, we have posted the primary outcome and safety outcomes on clinicaltrials.gov. https://clinicaltrials.gov/study/NCT02858583 on July 17 223. Not sure what the time frame will be for the results to be released on their webpage.
What was 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.
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.
What outcomes did we report on clinicaltrials.gov?
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.
What are the next steps?
We are planing 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, send me an email on email@example.com.
I would like to give my appreciation to the parents who consented 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.